Gingival Recession
Conditions
Brief summary
The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2) post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized tissue change (KTC) were also calculated.
Detailed description
Given the encouraging effects of platelet-rich fibrin (PRF) in healing and regeneration, it has been hypothesized that PRF might develop the outcomes obtained with coronally advanced flap (CAF)+connective tissue graft(CTG). Therefore, it was aimed to evaluate the effectiveness of CAF + CTG + PRF in Miller Class I and II recession defect treatment by comparing the outcomes with CAF + CTG in a preliminary, controlled, randomized clinical trial (RCT) with a 6-month follow-up. The study was conducted with 40 patients randomly grouped in half shares into indicated study groups. After phase I therapy, clinical variables including plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded. The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group. The CAF was primarily closed and postoperative instructions were given. After suture removal at second postoperative week, the patients were followed-up by monthly recall visits. Same periodontal clinical variables were recorded 3 and 6 months after surgery.
Interventions
BIOLOGICALplatelet-rich fibrin
autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
PROCEDUREconnective tissue graft
connective tissue graft was harvested from the palatal region of each patient by single incision method
PROCEDUREcoronally advanced flap
buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
Sponsors
Kırıkkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Systemically healthy * Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area * No alveolar bone loss * Identifiable cemento-enamel junction * Probing depth ≤3mm
Exclusion criteria
* Smoking * Pregnancy * History of periodontal surgery in last two years * Mobility * Excessive occlusal contacts * Caries * Loss of vitality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vertical Recession | Baseline, 6 weeks and 6 months | Measured from cementoenamel junction to margin of the gingiva by periodontal probe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal Recession | Baseline, 6 weeks and 6 months | measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe |
| Probing Depth | Baseline, 6 weeks and 6 months | measured from margin of the gingiva to gingival sulcus base by periodontal probe |
| Attachment Level | Baseline, 6 weeks and 6 months | measured from cementoenamel junction to gingival sulcus base by periodontal probe |
| Keratinized Tissue Width | Baseline, 6 weeks and 6 months | measured from margin of the gingiva to mucogingival junction by periodontal probe |
| Tissue Thickness | Baseline, 6 weeks and 6 months | under local anesthesia, measured from 1.5 mm below the margin of the gingiva with a spreader and its stopper silicon disc. Then, distance of the marked point was measured by using a standardized caliper to the closest 0.1 mm by periodontal probe |
Participant flow
Pre-assignment details
Fifty-eight patients that did not comply with the inclusion criteria were not chosen for the study
Participants by arm
| Arm | Count |
|---|---|
| CAF+CTG+PRF A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1 The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group and the CAF was primarily closed. | 20 |
| CAF+CTG A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1 The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. CTG was placed over the exposed root surface and the CAF was primarily closed onto it. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | CAF+CTG+PRF | CAF+CTG |
|---|---|---|---|
| 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 | 40 Participants | 20 Participants | 20 Participants |
| Age, Continuous | 40.72 years STANDARD_DEVIATION 7.18 | 41.80 years STANDARD_DEVIATION 7.85 | 39.65 years STANDARD_DEVIATION 6.46 |
| Region of Enrollment Turkey | 40 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Female | 27 Participants | 12 Participants | 15 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Vertical Recession
Measured from cementoenamel junction to margin of the gingiva by periodontal probe
Time frame: Baseline, 6 weeks and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRF+CAF+CTG | Vertical Recession | Baseline | 3.35 mm | Standard Deviation 0.43 |
| PRF+CAF+CTG | Vertical Recession | 6 weeks | 0.38 mm | Standard Deviation 0.54 |
| PRF+CAF+CTG | Vertical Recession | 6 months | 0.35 mm | Standard Deviation 0.52 |
| CAF+CTG | Vertical Recession | 6 months | 0.65 mm | Standard Deviation 0.59 |
| CAF+CTG | Vertical Recession | Baseline | 3.20 mm | Standard Deviation 0.34 |
| CAF+CTG | Vertical Recession | 6 weeks | 0.65 mm | Standard Deviation 0.59 |
Comparison: Baselinep-value: 0.259Mann-Whitney
Comparison: 6 weeksp-value: 0.097Mann-Whitney
Comparison: 6 monthsp-value: 0.07Mann-Whitney U
Secondary
Attachment Level
measured from cementoenamel junction to gingival sulcus base by periodontal probe
Time frame: Baseline, 6 weeks and 6 months
Population: Data pertaining to 20 patients from each group were analysed after completing 6 months period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PRF+CAF+CTG | Attachment Level | Baseline | 4.5 mm |
| PRF+CAF+CTG | Attachment Level | 6 weeks | 1 mm |
| PRF+CAF+CTG | Attachment Level | 6 months | 1 mm |
| CAF+CTG | Attachment Level | Baseline | 4 mm |
| CAF+CTG | Attachment Level | 6 weeks | 2 mm |
| CAF+CTG | Attachment Level | 6 months | 1.8 mm |
Comparison: Baselinep-value: 0.136Mann-Whitney
Comparison: 6 weeksp-value: 0.041Mann-Whitney
Comparison: 6 monthsp-value: 0.064Mann-Whitney U
Secondary
Horizontal Recession
measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe
Time frame: Baseline, 6 weeks and 6 months
Population: Data pertaining to 20 patients from each group were analysed after completing 6 months period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PRF+CAF+CTG | Horizontal Recession | Baseline | 3.8 mm |
| PRF+CAF+CTG | Horizontal Recession | 6 weeks | 0 mm |
| PRF+CAF+CTG | Horizontal Recession | 6 months | 0 mm |
| CAF+CTG | Horizontal Recession | Baseline | 3 mm |
| CAF+CTG | Horizontal Recession | 6 weeks | 1 mm |
| CAF+CTG | Horizontal Recession | 6 months | 1 mm |
Comparison: Baselinep-value: 0.067Mann-Whitney
Comparison: 6 weeksp-value: 0.13Mann-Whitney
Comparison: 6 monthsp-value: 0.128Mann-Whitney U
Secondary
Keratinized Tissue Width
measured from margin of the gingiva to mucogingival junction by periodontal probe
Time frame: Baseline, 6 weeks and 6 months
Population: Data pertaining to 20 patients from each group were analysed after completing 6 months period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PRF+CAF+CTG | Keratinized Tissue Width | Baseline | 3 mm |
| PRF+CAF+CTG | Keratinized Tissue Width | 6 weeks | 4 mm |
| PRF+CAF+CTG | Keratinized Tissue Width | 6 months | 4 mm |
| CAF+CTG | Keratinized Tissue Width | Baseline | 2.8 mm |
| CAF+CTG | Keratinized Tissue Width | 6 weeks | 3.5 mm |
| CAF+CTG | Keratinized Tissue Width | 6 months | 3.8 mm |
Comparison: Baselinep-value: 0.245Mann-Whitney
Comparison: 6 weeksp-value: 0.099Mann-Whitney
p-value: 0.077Mann-Whitney U
Secondary
Probing Depth
measured from margin of the gingiva to gingival sulcus base by periodontal probe
Time frame: Baseline, 6 weeks and 6 months
Population: Data pertaining to 20 patients from each group were analysed after completing 6 months period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PRF+CAF+CTG | Probing Depth | Baseline | 1 mm |
| PRF+CAF+CTG | Probing Depth | 6 weeks | 1 mm |
| PRF+CAF+CTG | Probing Depth | 6 months | 1 mm |
| CAF+CTG | Probing Depth | Baseline | 1 mm |
| CAF+CTG | Probing Depth | 6 weeks | 1 mm |
| CAF+CTG | Probing Depth | 6 months | 1 mm |
Comparison: Baselinep-value: 0.298Mann-Whitney
Comparison: 6 weeksp-value: 0.152Mann-Whitney
Comparison: 6 monthsp-value: 0.317Mann-Whitney U
Secondary
Tissue Thickness
under local anesthesia, measured from 1.5 mm below the margin of the gingiva with a spreader and its stopper silicon disc. Then, distance of the marked point was measured by using a standardized caliper to the closest 0.1 mm by periodontal probe
Time frame: Baseline, 6 weeks and 6 months
Population: Data pertaining to 20 patients from each group were analysed after completing 6 months period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PRF+CAF+CTG | Tissue Thickness | 6 weeks | 1.9 mm |
| PRF+CAF+CTG | Tissue Thickness | Baseline | 0.9 mm |
| PRF+CAF+CTG | Tissue Thickness | 6 months | 1.9 mm |
| CAF+CTG | Tissue Thickness | 6 weeks | 1.6 mm |
| CAF+CTG | Tissue Thickness | Baseline | 0.9 mm |
| CAF+CTG | Tissue Thickness | 6 months | 1.5 mm |
Comparison: Baselinep-value: 0.946Mann-Whitney
Comparison: 6 weeksp-value: 0.001Mann-Whitney
Comparison: 6 monthsp-value: 0.001Mann-Whitney U