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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRF+CAF+CTG | Experimental | platelet-rich fibrin + coronally advanced flap + connective tissue graft |
|
| CAF+CTG | Active Comparator | coronally advanced flap + connective tissue graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platelet-rich fibrin | Biological | autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vertical Recession | Measured from cementoenamel junction to margin of the gingiva by periodontal probe | Baseline, 6 weeks and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Horizontal Recession | measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe | Baseline, 6 weeks and 6 months |
| Probing Depth |
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Inclusion Criteria:
Exclusion Criteria:
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Fifty-eight patients that did not comply with the inclusion criteria were not chosen for the study
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| ID | Title | Description |
|---|---|---|
| FG000 | CAF+CTG+PRF | platelet-rich fibrin + coronally advanced flap + connective tissue graft platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method coronally 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) |
| FG001 | CAF+CTG | coronally advanced flap + connective tissue graft connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vertical Recession | Measured from cementoenamel junction to margin of the gingiva by periodontal probe | Posted | Mean | Standard Deviation | mm | Baseline, 6 weeks and 6 months |
|
6 months
At each visit, the patients were asked if they had such an experience of long-term swelling (more than 7 days), severe pain that did not response to analgesic consumption, ongoing bleeding (more than two days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRF+CAF+CTG | platelet-rich fibrin + coronally advanced flap + connective tissue graft platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method coronally 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. H. Gencay Keceli | Kirikkale University | +905326714377 | monsieur_gencay@yahoo.com |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| connective tissue graft | Procedure | connective tissue graft was harvested from the palatal region of each patient by single incision method |
|
| coronally advanced flap | Procedure | buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel) |
|
measured from margin of the gingiva to gingival sulcus base by periodontal probe
| Baseline, 6 weeks and 6 months |
| Attachment Level | measured from cementoenamel junction to gingival sulcus base by periodontal probe | Baseline, 6 weeks and 6 months |
| Keratinized Tissue Width | measured from margin of the gingiva to mucogingival junction by periodontal probe | Baseline, 6 weeks and 6 months |
| 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 | Baseline, 6 weeks and 6 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally 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)
|
|
|
| Secondary | Horizontal Recession | measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe | Data pertaining to 20 patients from each group were analysed after completing 6 months period | Posted | Median | Inter-Quartile Range | mm | Baseline, 6 weeks and 6 months |
|
|
|
|
| Secondary | Probing Depth | measured from margin of the gingiva to gingival sulcus base by periodontal probe | Data pertaining to 20 patients from each group were analysed after completing 6 months period | Posted | Median | Inter-Quartile Range | mm | Baseline, 6 weeks and 6 months |
|
|
|
|
| Secondary | Attachment Level | measured from cementoenamel junction to gingival sulcus base by periodontal probe | Data pertaining to 20 patients from each group were analysed after completing 6 months period | Posted | Median | Inter-Quartile Range | mm | Baseline, 6 weeks and 6 months |
|
|
|
|
| Secondary | Keratinized Tissue Width | measured from margin of the gingiva to mucogingival junction by periodontal probe | Data pertaining to 20 patients from each group were analysed after completing 6 months period | Posted | Median | Inter-Quartile Range | mm | Baseline, 6 weeks and 6 months |
|
|
|
|
| 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 | Data pertaining to 20 patients from each group were analysed after completing 6 months period | Posted | Median | Inter-Quartile Range | mm | Baseline, 6 weeks and 6 months |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | CAF+CTG | coronally advanced flap + connective tissue graft connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft | 0 | 20 | 0 | 20 | 0 | 20 |
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| D055093 |
| Periodontal Atrophy |
| 6 months |
|
| Superiority |
| 6 months | Mann-Whitney U | 0.128 | <0.05 | Superiority |
| 6 months |
|
| Superiority |
| 6 months | Mann-Whitney U | 0.317 | <0.05 | Superiority |
| 6 months |
|
| Superiority |
| 6 months | Mann-Whitney U | 0.064 | <0.05 | Superiority |
| 6 months |
|
| Superiority |
| Mann-Whitney U | 0.077 | Superiority |
| 6 months |
|
| Superiority |
| 6 months | Mann-Whitney U | 0.001 | <0.05 | Superiority |