Gingival Recession
Conditions
Keywords
root coverage
Brief summary
This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.
Detailed description
The study population will be divided into 2 groups: Group 1: Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft. The patients should be non-smoker, medically free and above 18 years Group 2: Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft and platelet rich fibrin. the patients should meet the same inclusion criteria mentionned above.
Interventions
PROCEDURECAF +SCTG
the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
OTHERplatelet rich fibrin
in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- 1) Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession. 3\) Clinical indication and/or patient request for recession coverage 4) Good oral hygiene
Exclusion criteria
\- 1) Miller Class III and IV gingival recession. 2) Any systemic diseases or any medication. 3) Pregnancy. 4) Patients undergoing radiotherapy. 5) Handicapped and mentally retarded patients. 6) Current and former smokers as smoking is a contra-indication for plastic periodontal surgery . 7\) Teeth with cervical restorations, abrasion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recession Depth | baseline-3 months-6 months | measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recession Width | baseline-3 months-6 months | It was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome. |
| Root Coverage Gain | at 6 months | (preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100. |
| Probing Depth | baseline-3 months-6 months | measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome. |
| Clinical Attachment Level | baseline-3 months-6 months | measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm). |
| Gingival Biotype | baseline-3 months-6 months | under local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome. |
| Width of Keratinized Gingiva | baseline-3 months-6 months | from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome. |
| Patient Satisfaction | questionnaire given to the patient 6 months after the surgery | printed yes/ no questionnaire with 3 questions: 1. would you do this surgery again? 2. would you recommend this treatment to others? 3. are you satisfied with the results? |
| Root Coverage Esthetic Score (RES) | 6 months | The RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES. minimum value:0 maximum value: 10 which means better outcome for RES |
| Post Operative Pain | after 2 weeks from surgery | Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively |
Countries
Egypt
Participant flow
Recruitment details
Subjects were selected from the outpatient clinic,Faculty of Dentistry, Cairo University between 30/09/2017 and 1/08/ 2019 Patients \>18 Periodontally and systemically healthy Miller class I or II buccal recession defects Presence of identifiable CEJ Clinical indication and/or patient request for recession coverage.
Pre-assignment details
5 patients were excluded for not meeting inclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| CAF+SCTG+PRF Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF) | 14 |
| CAF+SCTG Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | CAF+SCTG+PRF | CAF+SCTG | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 14 Participants | 28 Participants |
| Race/Ethnicity, Customized white non hispanic | 14 Participants | 14 Participants | 28 Participants |
| Region of Enrollment Egypt | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Recession Depth
measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.
Time frame: baseline-3 months-6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention: CAF+SCTG+PRF | Recession Depth | baseline | 2 length in millimeters |
| Intervention: CAF+SCTG+PRF | Recession Depth | 3 months | 0 length in millimeters |
| Intervention: CAF+SCTG+PRF | Recession Depth | 6 months | 0 length in millimeters |
| Control Group:CAF+SCTG | Recession Depth | baseline | 2 length in millimeters |
| Control Group:CAF+SCTG | Recession Depth | 3 months | 0 length in millimeters |
| Control Group:CAF+SCTG | Recession Depth | 6 months | 0 length in millimeters |
Secondary
Clinical Attachment Level
measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm).
Time frame: baseline-3 months-6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: CAF+SCTG+PRF | Clinical Attachment Level | baseline | 3.79 length in millimeters(mm) | Standard Deviation 0.97 |
| Intervention: CAF+SCTG+PRF | Clinical Attachment Level | 3 months | 2.14 length in millimeters(mm) | Standard Deviation 0.66 |
| Intervention: CAF+SCTG+PRF | Clinical Attachment Level | 6 months | 2 length in millimeters(mm) | Standard Deviation 0.69 |
| Control Group:CAF+SCTG | Clinical Attachment Level | baseline | 4 length in millimeters(mm) | Standard Deviation 0.78 |
| Control Group:CAF+SCTG | Clinical Attachment Level | 3 months | 2.29 length in millimeters(mm) | Standard Deviation 0.73 |
| Control Group:CAF+SCTG | Clinical Attachment Level | 6 months | 2.07 length in millimeters(mm) | Standard Deviation 0.62 |
Secondary
Gingival Biotype
under local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome.
Time frame: baseline-3 months-6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention: CAF+SCTG+PRF | Gingival Biotype | baseline | 1 length in millimeters(mm) |
| Intervention: CAF+SCTG+PRF | Gingival Biotype | 3 months | 3 length in millimeters(mm) |
| Intervention: CAF+SCTG+PRF | Gingival Biotype | 6 months | 3 length in millimeters(mm) |
| Control Group:CAF+SCTG | Gingival Biotype | baseline | 1 length in millimeters(mm) |
| Control Group:CAF+SCTG | Gingival Biotype | 3 months | 2.5 length in millimeters(mm) |
| Control Group:CAF+SCTG | Gingival Biotype | 6 months | 3 length in millimeters(mm) |
Secondary
Patient Satisfaction
printed yes/ no questionnaire with 3 questions: 1. would you do this surgery again? 2. would you recommend this treatment to others? 3. are you satisfied with the results?
Time frame: questionnaire given to the patient 6 months after the surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: CAF+SCTG+PRF | Patient Satisfaction | 71.4 percentage of patients satisfied |
| Control Group:CAF+SCTG | Patient Satisfaction | 64.3 percentage of patients satisfied |
Secondary
Post Operative Pain
Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively
Time frame: after 2 weeks from surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention: CAF+SCTG+PRF | Post Operative Pain | 9 score on a scale |
| Control Group:CAF+SCTG | Post Operative Pain | 8.5 score on a scale |
Secondary
Probing Depth
measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome.
Time frame: baseline-3 months-6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: CAF+SCTG+PRF | Probing Depth | baseline | 1.71 length in millimeters(mm) | Standard Deviation 0.47 |
| Intervention: CAF+SCTG+PRF | Probing Depth | 3 months | 1.07 length in millimeters(mm) | Standard Deviation 0.27 |
| Intervention: CAF+SCTG+PRF | Probing Depth | 6 months | 1.07 length in millimeters(mm) | Standard Deviation 0.27 |
| Control Group:CAF+SCTG | Probing Depth | baseline | 1.5 length in millimeters(mm) | Standard Deviation 0.65 |
| Control Group:CAF+SCTG | Probing Depth | 3 months | 1.07 length in millimeters(mm) | Standard Deviation 0.27 |
| Control Group:CAF+SCTG | Probing Depth | 6 months | 1.21 length in millimeters(mm) | Standard Deviation 0.27 |
Secondary
Recession Width
It was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome.
Time frame: baseline-3 months-6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention: CAF+SCTG+PRF | Recession Width | baseline | 1.5 length in millimeters (mm) |
| Intervention: CAF+SCTG+PRF | Recession Width | 3 months | 0 length in millimeters (mm) |
| Intervention: CAF+SCTG+PRF | Recession Width | 6 months | 0 length in millimeters (mm) |
| Control Group:CAF+SCTG | Recession Width | baseline | 2 length in millimeters (mm) |
| Control Group:CAF+SCTG | Recession Width | 3 months | 0 length in millimeters (mm) |
| Control Group:CAF+SCTG | Recession Width | 6 months | 0 length in millimeters (mm) |
Secondary
Root Coverage Esthetic Score (RES)
The RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES. minimum value:0 maximum value: 10 which means better outcome for RES
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: CAF+SCTG+PRF | Root Coverage Esthetic Score (RES) | 9.43 score on a scale | Standard Deviation 1.09 |
| Control Group:CAF+SCTG | Root Coverage Esthetic Score (RES) | 9.29 score on a scale | Standard Deviation 1.27 |
Secondary
Root Coverage Gain
(preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.
Time frame: at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: CAF+SCTG+PRF | Root Coverage Gain | 92.9 percentage of root coverage | Standard Deviation 18.2 |
| Control Group:CAF+SCTG | Root Coverage Gain | 91.6 percentage of root coverage | Standard Deviation 17.1 |
Secondary
Width of Keratinized Gingiva
from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome.
Time frame: baseline-3 months-6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: CAF+SCTG+PRF | Width of Keratinized Gingiva | baseline | 2.36 length in millimeters(mm) | Standard Deviation 0.63 |
| Intervention: CAF+SCTG+PRF | Width of Keratinized Gingiva | 3 months | 3.64 length in millimeters(mm) | Standard Deviation 1.08 |
| Intervention: CAF+SCTG+PRF | Width of Keratinized Gingiva | 6 months | 3.86 length in millimeters(mm) | Standard Deviation 1.03 |
| Control Group:CAF+SCTG | Width of Keratinized Gingiva | baseline | 2.64 length in millimeters(mm) | Standard Deviation 0.74 |
| Control Group:CAF+SCTG | Width of Keratinized Gingiva | 3 months | 3.71 length in millimeters(mm) | Standard Deviation 0.73 |
| Control Group:CAF+SCTG | Width of Keratinized Gingiva | 6 months | 4.14 length in millimeters(mm) | Standard Deviation 0.86 |