Back to resultsGrowth Factors in the Treatment of the Multiple Gingival Recessions
Primary Purpose
Growth Factors, Combined Defect of, Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CAF only
CAF+CGF
CAF+A-PRF
Sponsored by
About this trial
This is an interventional treatment trial for Growth Factors, Combined Defect of
Eligibility Criteria
Inclusion Criteria:
- Systematically and periodontally healthy non-smokers
- Presence of Cairo Recession type I gingival recession with ≥ 2 mm gingival recession depth, probing depth <3 mm and gingival thickness (GT) ≥ 0.8 mm on both sides of the maxillary arch
- Width of keratinized gingiva ≥ 2mm
- Presence of identifiable cemento-enamel junction
- Full-mouth plaque index (PI) < 20 %
- Gingival index (GI) scores =1
- Presence of tooth vitality
- Absence of caries, restorations and furcation involvement in the treated area
Exclusion Criteria:
- Patients who had systemic problems that wound contraindicate for periodontal surgery
- Usage of medications known to interfere with healing and to cause gingival enlargement
- Recession defects associated with demineralization, deep abrasion, previous surgery in the defects area within the past 1 year
- Pregnant or lactating females
- Drug and alcohol abuse
Sites / Locations
- Figen Öngöz Dede
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
CAF only
CAF+CGF
CAF+A-PRF
Arm Description
Only Coronally Advanced Flap technique
Concentrated Growth Factor (CGF) applied together with Coronally Advanced Flap (CAF) technique
Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique
Outcomes
Primary Outcome Measures
Complete and mean root coverage
Percentages of root coverage and complete root coverage were calculated according to the following standard formulae.
Percentage of root coverage: [(preop. vertical gingival recession (VGR)- postop.VGR)\ preop. VGR] x 100 Percentage of complete root coverage: [(teeth with complete root coverage) \ (all treated teeth)] x 100.
Secondary Outcome Measures
Gingival thickness
The gingival thickness was evaluated midbuccally in the attached gingival (GT-MB), halfway between the mucogingival junction and free gingival groove and at the base of the interdental papilla. GT was measured by using a periodontal probe with a rubber stopper under local anesthesia, and then the thickness was assessed by transferring to an electronic digital caliper.
Keratinized gingiva width (WKG)
The WKG was determined by subtracting the VGR from the CEJ- MGJ (mucogingival junction).
Patient esthetic score (PES)
Patient esthetic score (PES) to evaluate esthetic appearance (color, appearance, and form of the selected site),
PES: bad-unlikely esthetics (score 0) → perfect esthetics (score 10)
Patient comfort score (PCS)
Patient comfort score (PCS) for the pain, edema and other experiences regarding operating technique, instruments, and microscopic view, etc.
PCS: unbearable discomfort (score 0) → no-discomfort (score 10).
Hypersensitivity score (HS)
"Hypersensitivity" score was recorded after blasting air (60 psi, 22°C) derived from a dental syringe that was heading for the root surface for 1 s. The syringe was held at 90° angle, 2-3 mm from the root surface. Neighboring teeth were shielded during testing with the dentist's gloved fingers; then the patient has enquired again to score the discomfort level.
HS: no pain (score 0) → worst pain imaginable (score 10)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05319938
Brief Title
Growth Factors in the Treatment of the Multiple Gingival Recessions
Official Title
Clinical Evaluation of Treatment With Micro-surgical Management of Type I Multiple Gingival Recessions Using Coronally Advanced Flap With Either Advanced Platelet-Rich Fibrin or Concentrated Growth Factor: A Comparative Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bulent Ecevit University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study was to compare and evaluate the clinical effects of Concentrated Growth Factor (CGF) and Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique using a microsurgical approach in the treatment of Type I multiple gingival recessions (GR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Factors, Combined Defect of, Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAF only
Arm Type
Active Comparator
Arm Description
Only Coronally Advanced Flap technique
Arm Title
CAF+CGF
Arm Type
Experimental
Arm Description
Concentrated Growth Factor (CGF) applied together with Coronally Advanced Flap (CAF) technique
Arm Title
CAF+A-PRF
Arm Type
Experimental
Arm Description
Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique
Intervention Type
Procedure
Intervention Name(s)
CAF only
Intervention Description
After local anesthesia, initially, sulcular incisions were made on the buccal aspect of the teeth and two vertical incisions were made. A trapezoidal flap was elevated with a split-full-split approach in the coronal-apical direction. The anatomic inter-dental papillae adjacent to the involved tooth were de-epithelialized. Plaque, calculus, and soft tooth structures on exposed root surfaces were removed with curettes. No further mechanical or chemical root conditioning materials were performed. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.
Intervention Type
Procedure
Intervention Name(s)
CAF+CGF
Intervention Description
After local anesthesia, initially, sulcular incisions were made on the buccal aspect of the teeth and two vertical incisions were made. A trapezoidal flap was elevated with a split-full-split approach in the coronal-apical direction. The anatomic inter-dental papillae adjacent to the involved tooth were de-epithelialized. Plaque, calculus, and soft tooth structures on exposed root surfaces were removed with curettes. No further mechanical or chemical root conditioning materials were performed. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.
Blood samples were collected into 10 ml glass-coated plastic tubes without anticoagulant solutions. These tubes were placed into CGF centrifuge machine and centrifuged immediately . CGF membrane were placed over the defect. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.
Intervention Type
Procedure
Intervention Name(s)
CAF+A-PRF
Intervention Description
After local anesthesia, initially, sulcular incisions were made on the buccal aspect of the teeth and two vertical incisions were made. A trapezoidal flap was elevated with a split-full-split approach in the coronal-apical direction. The anatomic inter-dental papillae adjacent to the involved tooth were de-epithelialized. Plaque, calculus, and soft tooth structures on exposed root surfaces were removed with curettes. No further mechanical or chemical root conditioning materials were performed. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.
Blood samples were collected into 10 ml glass-coated plastic tubes without anticoagulant solutions. These tubes were placed into A-PRF centrifuge machine and centrifuged immediately. A-PRF membrane were placed over the defect. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.
Primary Outcome Measure Information:
Title
Complete and mean root coverage
Description
Percentages of root coverage and complete root coverage were calculated according to the following standard formulae.
Percentage of root coverage: [(preop. vertical gingival recession (VGR)- postop.VGR)\ preop. VGR] x 100 Percentage of complete root coverage: [(teeth with complete root coverage) \ (all treated teeth)] x 100.
Time Frame
Change from baseline at 6 months of the percent of complete and mean root coverage
Secondary Outcome Measure Information:
Title
Gingival thickness
Description
The gingival thickness was evaluated midbuccally in the attached gingival (GT-MB), halfway between the mucogingival junction and free gingival groove and at the base of the interdental papilla. GT was measured by using a periodontal probe with a rubber stopper under local anesthesia, and then the thickness was assessed by transferring to an electronic digital caliper.
Time Frame
Change from baseline at 6 months of the gingival thickness
Title
Keratinized gingiva width (WKG)
Description
The WKG was determined by subtracting the VGR from the CEJ- MGJ (mucogingival junction).
Time Frame
Change from baseline at 6 months of keratinized gingiva width
Title
Patient esthetic score (PES)
Description
Patient esthetic score (PES) to evaluate esthetic appearance (color, appearance, and form of the selected site),
PES: bad-unlikely esthetics (score 0) → perfect esthetics (score 10)
Time Frame
Change from baseline at 6 months of the patient esthetic score
Title
Patient comfort score (PCS)
Description
Patient comfort score (PCS) for the pain, edema and other experiences regarding operating technique, instruments, and microscopic view, etc.
PCS: unbearable discomfort (score 0) → no-discomfort (score 10).
Time Frame
Change from baseline at 6 months of the patient comfort score
Title
Hypersensitivity score (HS)
Description
"Hypersensitivity" score was recorded after blasting air (60 psi, 22°C) derived from a dental syringe that was heading for the root surface for 1 s. The syringe was held at 90° angle, 2-3 mm from the root surface. Neighboring teeth were shielded during testing with the dentist's gloved fingers; then the patient has enquired again to score the discomfort level.
HS: no pain (score 0) → worst pain imaginable (score 10)
Time Frame
Change from baseline at 6 months of the hypersensitivity score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systematically and periodontally healthy non-smokers
Presence of Cairo Recession type I gingival recession with ≥ 2 mm gingival recession depth, probing depth <3 mm and gingival thickness (GT) ≥ 0.8 mm on both sides of the maxillary arch
Width of keratinized gingiva ≥ 2mm
Presence of identifiable cemento-enamel junction
Full-mouth plaque index (PI) < 20 %
Gingival index (GI) scores =1
Presence of tooth vitality
Absence of caries, restorations and furcation involvement in the treated area
Exclusion Criteria:
Patients who had systemic problems that wound contraindicate for periodontal surgery
Usage of medications known to interfere with healing and to cause gingival enlargement
Recession defects associated with demineralization, deep abrasion, previous surgery in the defects area within the past 1 year
Pregnant or lactating females
Drug and alcohol abuse
Facility Information:
Facility Name
Figen Öngöz Dede
City
Ordu
ZIP/Postal Code
52100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Growth Factors in the Treatment of the Multiple Gingival Recessions
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