Malocclusion
Conditions
Keywords
periodontal accelerated osteogenic orthodontics, vertical releasing incision
Brief summary
The study aims to compare the effect of periodontal accelerated osteogenic orthodontics (PAOO) with horizontal or vertical releasing incisions on operation time, healing, adverse effects, and effectiveness of bone augmentation. Methods: A total of 22 patients requiring PAOO surgery due to orthodontic treatment were enrolled in this trial, and randomly divided into test or control group, consisting of 11 subjects in each. The test group will receive PAOO with horizontal extending incisions on both sides of the flap; while the control group will receive PAOO with vertical releasing incisions; the two groups use the same surgical technic except for the incision design. Outcome measures include: operation time, postoperative scar, radiographic data (alveolar height and alveolar ridge thickness), gingival thickness, etc. Clinical evaluation will be performed at 1 week, 2 weeks, 3months, 6 months and 12 months after operation.
Interventions
PROCEDUREhorizontal extending incision
a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
PROCEDUREvertical releasing incision
a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged between 18 and 40 years old, systemic healthy, undergoing or planning to undergo orthodontic treatment. 2. Patients with a thin alveolar bone or with dehiscence and/or fenestration on the labial side of maxillary or mandibular front teeth area. 3. Patients with expected tooth movement beyond the labial alveolar bone during orthodontic procedures.
Exclusion criteria
1. Smoker. 2. Pregnant or lactating. 3. Untreated periodontitis. 4. Presence of \<2mm keratinized gingival width(KGW) or thin gingival phenotype (as defined by dental probe transparency.) 5. History of orthodontic and/or orthognathic treatment. 6. With systemic disease (diabetes, hypertension, heart disease, malignant tumor, severe mental illness, and other surgical contraindications.) 7. Long-term medication (immunosuppressive drugs, bisphosphonates, etc.) 8. Poor adherence to complete one-year follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgery Time | 1 day | Timing will start when the first incision is about to be made, and end when the last suture is complete. The time in between will be recorded as surgery time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth (PD) | 12 months | Distance from gingival margin to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery. |
| Clinical Attachment Level (CAL) | 12 months | Distance from CEJ to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery. |
| Keratinized Gingival Width (KGW) | 12 months | From mucogingival junction to free gingival margin It will be measured at baseline and 3 months, 6 months, and 12months after surgery. |
| Gingival Recession Depth (GRD) | 12 months | Distance from CEJ to gingival margin. It will be measured at baseline and 3 months, 6 months, and 12months after surgery. |
| Root Length | 12 months | the distance from the CEJ to the apex of the root. It will be measured at baseline, 6 months, and 12months after surgery. |
| Vertical Bone Height (VBL) | 12 months | the distance from the cemento-enamel junction to the crest of the labial alveolar bone. It will be measured at baseline, 6 months, and 12months after surgery. |
| Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2) | 12 months | Alveolar bone width measured at 2 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery. |
| Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6) | 12 months | Alveolar bone width measured at 6 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery. |
| Number of Participants With Visible Scarring | 12 months | Gingival scarring was evaluated at 12 months postoperatively through visual inspection. Participants were classified as scar-positive if any visible scar was present at the surgical site, including normotrophic scars (flat and white) and pathological scars (raised or irregular in shape). Each participant was counted once regardless of scar characteristics. |
| Pain Level | 2 weeks | measured with visual analogue score (VAS): 0 (no pain/normal sensation) to 10 (intolerable pain/complete numbness) |
| Membrane Exposure | 2 weeks | membrane exposure was observed and assessed as a binary outcome (yes/no). Recorded no if there is no membrane exposure, and yes if there is any membrane exposure. |
| Facial Swelling | 2 weeks | recorded 0 for no facial swelling; 1 for mild facial swelling; 2 for severe facial swelling. It will be measured at 1 and 2 weeks after surgery. |
| Mucosal Color | 2 weeks | recorded 0 for no redness along the incision; 1 for slight redness; 2 for obvious redness. It will be measured at 1 and 2 weeks after surgery. |
| Mucosa Edema | 2 weeks | recorded 0 for no edema around the surgery area; 1 for mild edema; 2 for severe edema.It will be measured at 1 and 2 weeks after surgery. |
| Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4) | 12 months | Alveolar bone width measured at 4 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Particulate Bone Grafting Material Weight | 1 day | The net weight of the bone graft material before surgery is recorded as W1. After surgery, the remaining bone graft material was collected, dried, and weighed by the same electronic scale as W2. The amount of bone graft material used during surgery was calculated as ΔW=W1-W2. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HEI Group Periodontal Accelerated Osteogenic Orthodontics (PAOO) with horizontally extending incisions on both sides
horizontally extending incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted. | 10 |
| HEI Group Periodontal Accelerated Osteogenic Orthodontics (PAOO) with horizontally extending incisions on both sides
horizontally extending incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted. | 60 |
| VRI Group Periodontal Accelerated Osteogenic Orthodontics (PAOO) with vertical releasing incisions on both sides
vertical releasing incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. | 10 |
| VRI Group Periodontal Accelerated Osteogenic Orthodontics (PAOO) with vertical releasing incisions on both sides
vertical releasing incision: a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. | 57 |
| Total | 137 |
Baseline characteristics
| Characteristic | HEI Group | VRI Group | Total |
|---|---|---|---|
| Age, Continuous | 27.20 years STANDARD_DEVIATION 4.64 | 27.20 years STANDARD_DEVIATION 5.07 | 27.20 years STANDARD_DEVIATION 4.73 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Surgery Time
Timing will start when the first incision is about to be made, and end when the last suture is complete. The time in between will be recorded as surgery time.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEI Group | Surgery Time | 57.66 minutes | Standard Deviation 5.01 |
| VRI Group | Surgery Time | 68.50 minutes | Standard Deviation 13.5 |
Secondary
Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)
Alveolar bone width measured at 2 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2) | baseline | 0.33 millimeter | Standard Deviation 0.47 |
| HEI Group | Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2) | 6 months change | 0.80 millimeter | Standard Deviation 0.86 |
| HEI Group | Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2) | 12 months change | 0.67 millimeter | Standard Deviation 0.78 |
| VRI Group | Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2) | baseline | 0.18 millimeter | Standard Deviation 0.4 |
| VRI Group | Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2) | 6 months change | 0.45 millimeter | Standard Deviation 0.69 |
| VRI Group | Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2) | 12 months change | 0.39 millimeter | Standard Deviation 0.67 |
Secondary
Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)
Alveolar bone width measured at 4 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4) | baseline | 0.43 millimeter | Standard Deviation 0.48 |
| HEI Group | Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4) | 6 months change | 1.71 millimeter | Standard Deviation 1 |
| HEI Group | Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4) | 12 months change | 1.44 millimeter | Standard Deviation 0.73 |
| VRI Group | Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4) | baseline | 0.39 millimeter | Standard Deviation 0.5 |
| VRI Group | Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4) | 6 months change | 0.96 millimeter | Standard Deviation 0.68 |
| VRI Group | Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4) | 12 months change | 0.94 millimeter | Standard Deviation 0.51 |
Secondary
Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)
Alveolar bone width measured at 6 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6) | baseline | 0.45 millimeter | Standard Deviation 0.5 |
| HEI Group | Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6) | 6 months change | 2.47 millimeter | Standard Deviation 1.11 |
| HEI Group | Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6) | 12 months change | 1.92 millimeter | Standard Deviation 0.87 |
| VRI Group | Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6) | baseline | 0.51 millimeter | Standard Deviation 0.46 |
| VRI Group | Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6) | 6 months change | 1.38 millimeter | Standard Deviation 0.85 |
| VRI Group | Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6) | 12 months change | 1.13 millimeter | Standard Deviation 0.68 |
Secondary
Clinical Attachment Level (CAL)
Distance from CEJ to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Clinical Attachment Level (CAL) | baseline | 0.66 millimeter | Standard Deviation 1.05 |
| HEI Group | Clinical Attachment Level (CAL) | 3 months change | 0.05 millimeter | Standard Deviation 0.77 |
| HEI Group | Clinical Attachment Level (CAL) | 6 months change | 0.01 millimeter | Standard Deviation 0.8 |
| HEI Group | Clinical Attachment Level (CAL) | 12 months change | 0.15 millimeter | Standard Deviation 0.85 |
| VRI Group | Clinical Attachment Level (CAL) | 12 months change | -0.15 millimeter | Standard Deviation 0.78 |
| VRI Group | Clinical Attachment Level (CAL) | baseline | 0.52 millimeter | Standard Deviation 0.89 |
| VRI Group | Clinical Attachment Level (CAL) | 6 months change | 0.16 millimeter | Standard Deviation 0.76 |
| VRI Group | Clinical Attachment Level (CAL) | 3 months change | 0.05 millimeter | Standard Deviation 0.75 |
Secondary
Facial Swelling
recorded 0 for no facial swelling; 1 for mild facial swelling; 2 for severe facial swelling. It will be measured at 1 and 2 weeks after surgery.
Time frame: 2 weeks
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HEI Group | Facial Swelling | 2 weeks | 1 | 0 Participants |
| HEI Group | Facial Swelling | 1 week | 0 | 6 Participants |
| HEI Group | Facial Swelling | 2 weeks | 0 | 10 Participants |
| HEI Group | Facial Swelling | 1 week | 1 | 4 Participants |
| HEI Group | Facial Swelling | 2 weeks | 2 | 0 Participants |
| HEI Group | Facial Swelling | 1 week | 2 | 0 Participants |
| VRI Group | Facial Swelling | 2 weeks | 2 | 0 Participants |
| VRI Group | Facial Swelling | 2 weeks | 0 | 10 Participants |
| VRI Group | Facial Swelling | 2 weeks | 1 | 0 Participants |
| VRI Group | Facial Swelling | 1 week | 2 | 0 Participants |
| VRI Group | Facial Swelling | 1 week | 0 | 4 Participants |
| VRI Group | Facial Swelling | 1 week | 1 | 6 Participants |
Secondary
Gingival Recession Depth (GRD)
Distance from CEJ to gingival margin. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Gingival Recession Depth (GRD) | baseline | -0.75 millimeter | Standard Deviation 1.03 |
| HEI Group | Gingival Recession Depth (GRD) | 3 months change | -0.06 millimeter | Standard Deviation 0.77 |
| HEI Group | Gingival Recession Depth (GRD) | 6 months change | -0.08 millimeter | Standard Deviation 0.99 |
| HEI Group | Gingival Recession Depth (GRD) | 12 months change | -0.04 millimeter | Standard Deviation 0.89 |
| VRI Group | Gingival Recession Depth (GRD) | 12 months change | 0.01 millimeter | Standard Deviation 0.77 |
| VRI Group | Gingival Recession Depth (GRD) | baseline | -0.96 millimeter | Standard Deviation 1.25 |
| VRI Group | Gingival Recession Depth (GRD) | 6 months change | 0.21 millimeter | Standard Deviation 0.7 |
| VRI Group | Gingival Recession Depth (GRD) | 3 months change | 0.14 millimeter | Standard Deviation 0.67 |
Secondary
Keratinized Gingival Width (KGW)
From mucogingival junction to free gingival margin It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Keratinized Gingival Width (KGW) | baseline | 2.97 millimeter | Standard Deviation 0.72 |
| HEI Group | Keratinized Gingival Width (KGW) | 3 months change | 0.50 millimeter | Standard Deviation 0.86 |
| HEI Group | Keratinized Gingival Width (KGW) | 6 months change | 0.37 millimeter | Standard Deviation 1.12 |
| HEI Group | Keratinized Gingival Width (KGW) | 12 months change | 0.85 millimeter | Standard Deviation 1.13 |
| VRI Group | Keratinized Gingival Width (KGW) | 12 months change | 0.71 millimeter | Standard Deviation 1.15 |
| VRI Group | Keratinized Gingival Width (KGW) | baseline | 3.50 millimeter | Standard Deviation 1.3 |
| VRI Group | Keratinized Gingival Width (KGW) | 6 months change | 0.41 millimeter | Standard Deviation 1.38 |
| VRI Group | Keratinized Gingival Width (KGW) | 3 months change | 0.07 millimeter | Standard Deviation 1.39 |
Secondary
Membrane Exposure
membrane exposure was observed and assessed as a binary outcome (yes/no). Recorded no if there is no membrane exposure, and yes if there is any membrane exposure.
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HEI Group | Membrane Exposure | yes | 3 Participants |
| HEI Group | Membrane Exposure | no | 7 Participants |
| VRI Group | Membrane Exposure | yes | 1 Participants |
| VRI Group | Membrane Exposure | no | 9 Participants |
Secondary
Mucosa Edema
recorded 0 for no edema around the surgery area; 1 for mild edema; 2 for severe edema.It will be measured at 1 and 2 weeks after surgery.
Time frame: 2 weeks
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HEI Group | Mucosa Edema | 1 week | 0 | 1 Participants |
| HEI Group | Mucosa Edema | 1 week | 1 | 7 Participants |
| HEI Group | Mucosa Edema | 1 week | 2 | 2 Participants |
| HEI Group | Mucosa Edema | 2 weeks | 0 | 3 Participants |
| HEI Group | Mucosa Edema | 2 weeks | 1 | 7 Participants |
| HEI Group | Mucosa Edema | 2 weeks | 2 | 0 Participants |
| VRI Group | Mucosa Edema | 2 weeks | 1 | 7 Participants |
| VRI Group | Mucosa Edema | 1 week | 0 | 0 Participants |
| VRI Group | Mucosa Edema | 2 weeks | 0 | 3 Participants |
| VRI Group | Mucosa Edema | 1 week | 1 | 6 Participants |
| VRI Group | Mucosa Edema | 2 weeks | 2 | 0 Participants |
| VRI Group | Mucosa Edema | 1 week | 2 | 4 Participants |
Secondary
Mucosal Color
recorded 0 for no redness along the incision; 1 for slight redness; 2 for obvious redness. It will be measured at 1 and 2 weeks after surgery.
Time frame: 2 weeks
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HEI Group | Mucosal Color | 1 week | 1 | 10 Participants |
| HEI Group | Mucosal Color | 2 weeks | 0 | 0 Participants |
| HEI Group | Mucosal Color | 1 week | 0 | 0 Participants |
| HEI Group | Mucosal Color | 2 weeks | 1 | 10 Participants |
| HEI Group | Mucosal Color | 1 week | 2 | 0 Participants |
| HEI Group | Mucosal Color | 2 weeks | 2 | 0 Participants |
| VRI Group | Mucosal Color | 1 week | 2 | 1 Participants |
| VRI Group | Mucosal Color | 1 week | 0 | 0 Participants |
| VRI Group | Mucosal Color | 1 week | 1 | 9 Participants |
| VRI Group | Mucosal Color | 2 weeks | 2 | 0 Participants |
| VRI Group | Mucosal Color | 2 weeks | 0 | 1 Participants |
| VRI Group | Mucosal Color | 2 weeks | 1 | 9 Participants |
Secondary
Number of Participants With Visible Scarring
Gingival scarring was evaluated at 12 months postoperatively through visual inspection. Participants were classified as scar-positive if any visible scar was present at the surgical site, including normotrophic scars (flat and white) and pathological scars (raised or irregular in shape). Each participant was counted once regardless of scar characteristics.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEI Group | Number of Participants With Visible Scarring | 1 Participants |
| VRI Group | Number of Participants With Visible Scarring | 6 Participants |
Secondary
Pain Level
measured with visual analogue score (VAS): 0 (no pain/normal sensation) to 10 (intolerable pain/complete numbness)
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Pain Level | 1 week | 2.90 score on a scale | Standard Deviation 1.2 |
| HEI Group | Pain Level | 2 weeks | 1.60 score on a scale | Standard Deviation 1.08 |
| VRI Group | Pain Level | 1 week | 2.70 score on a scale | Standard Deviation 1.16 |
| VRI Group | Pain Level | 2 weeks | 1.50 score on a scale | Standard Deviation 1.08 |
Secondary
Probing Depth (PD)
Distance from gingival margin to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Probing Depth (PD) | baseline | 1.86 millimeter | Standard Deviation 0.32 |
| HEI Group | Probing Depth (PD) | 3 months change | -0.05 millimeter | Standard Deviation 0.45 |
| HEI Group | Probing Depth (PD) | 6 months change | 0.03 millimeter | Standard Deviation 0.43 |
| HEI Group | Probing Depth (PD) | 12 months change | -0.07 millimeter | Standard Deviation 0.58 |
| VRI Group | Probing Depth (PD) | 12 months change | -0.05 millimeter | Standard Deviation 0.59 |
| VRI Group | Probing Depth (PD) | baseline | 1.86 millimeter | Standard Deviation 1.83 |
| VRI Group | Probing Depth (PD) | 6 months change | 0.13 millimeter | Standard Deviation 0.56 |
| VRI Group | Probing Depth (PD) | 3 months change | 0.06 millimeter | Standard Deviation 0.42 |
Secondary
Root Length
the distance from the CEJ to the apex of the root. It will be measured at baseline, 6 months, and 12months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Root Length | baseline | 11.11 millimeter | Standard Deviation 1.81 |
| HEI Group | Root Length | 6 months change | -0.30 millimeter | Standard Deviation 0.78 |
| HEI Group | Root Length | 12 months change | -0.44 millimeter | Standard Deviation 1 |
| VRI Group | Root Length | baseline | 12.03 millimeter | Standard Deviation 2.45 |
| VRI Group | Root Length | 6 months change | -0.45 millimeter | Standard Deviation 1.09 |
| VRI Group | Root Length | 12 months change | -064 millimeter | Standard Deviation 1.09 |
Secondary
Vertical Bone Height (VBL)
the distance from the cemento-enamel junction to the crest of the labial alveolar bone. It will be measured at baseline, 6 months, and 12months after surgery.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HEI Group | Vertical Bone Height (VBL) | baseline | 4.28 millimeter | Standard Deviation 2.99 |
| HEI Group | Vertical Bone Height (VBL) | 6 months change | -2.95 millimeter | Standard Deviation 2.75 |
| HEI Group | Vertical Bone Height (VBL) | 12 months change | -2.69 millimeter | Standard Deviation 2.96 |
| VRI Group | Vertical Bone Height (VBL) | baseline | 5.06 millimeter | Standard Deviation 3 |
| VRI Group | Vertical Bone Height (VBL) | 6 months change | -3.17 millimeter | Standard Deviation 2.76 |
| VRI Group | Vertical Bone Height (VBL) | 12 months change | -2.94 millimeter | Standard Deviation 2.79 |
Other Pre-specified
Particulate Bone Grafting Material Weight
The net weight of the bone graft material before surgery is recorded as W1. After surgery, the remaining bone graft material was collected, dried, and weighed by the same electronic scale as W2. The amount of bone graft material used during surgery was calculated as ΔW=W1-W2.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEI Group | Particulate Bone Grafting Material Weight | 0.83 g | Standard Deviation 0.23 |
| VRI Group | Particulate Bone Grafting Material Weight | 0.79 g | Standard Deviation 0.25 |