Growth Factors in the Treatment of the Multiple Gingival Recessions

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319938
• Other study ID #: HD-1726
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2022
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Growth Factors, Combined Defect of

Intervention

Procedure:
• CAF only
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.
• CAF+CGF
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.
• CAF+A-PRF
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.

Locations

Country	Name	City	State
Turkey	Figen Öngöz Dede	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 6 months of the percent of complete and mean root coverage
Secondary	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.	Change from baseline at 6 months of the gingival thickness
Secondary	Keratinized gingiva width (WKG)	The WKG was determined by subtracting the VGR from the CEJ- MGJ (mucogingival junction).	Change from baseline at 6 months of keratinized gingiva width
Secondary	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)	Change from baseline at 6 months of the patient esthetic score
Secondary	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).	Change from baseline at 6 months of the patient comfort score
Secondary	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)	Change from baseline at 6 months of the hypersensitivity score