Growth Factors in the Treatment of the Multiple Gingival Recessions

NCT05319938 | Completed

• 1 other identifier: HD-1726
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Growth Factors, Combined Defect of; Gingival Recession

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Gingival thickness

  Change from baseline at 6 months of the gingival thickness

• Keratinized gingiva width (WKG)

  Change from baseline at 6 months of keratinized gingiva width

• Patient esthetic score (PES)

  Change from baseline at 6 months of the patient esthetic score

• Patient comfort score (PCS)

  Change from baseline at 6 months of the patient comfort score

• Hypersensitivity score (HS)

  Change from baseline at 6 months of the hypersensitivity score

Study Arms (3)

CAF only

ACTIVE COMPARATOR

Only Coronally Advanced Flap technique

Procedure: CAF only

CAF+CGF

EXPERIMENTAL

Concentrated Growth Factor (CGF) applied together with Coronally Advanced Flap (CAF) technique

Procedure: CAF+CGF

CAF+A-PRF

EXPERIMENTAL

Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique

Procedure: CAF+A-PRF

Interventions

CAF only PROCEDURE

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 only

CAF+CGF PROCEDURE

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+CGF

CAF+A-PRF PROCEDURE

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.

CAF+A-PRF

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Sites (1)

Figen Öngöz Dede

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Growth Factors, Combined Defect of; Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Association Professor

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 11, 2022
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

TU (1)