Periosteal Pedicle Flap Versus Subepithelial Connective Tissue Graft in Management of Gingival Recession

Can a Periosteal Pedicle Flap Replace the Subepithelial Connective Tissue Graft in the Management of Gingival Recession? Randomized Controlled Clinical Trial

Gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (CEJ).Various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the treatment of gingival recession.The present gold standard technique is the bilaminar technique using the subepithelial connective tissue graft (SCTG) which provides for long-term stability but also increases tissue morbidity.Hence, a suitable alternative technique - the periosteal pedicle flap (PPF) - has been practiced, which is less invasive, does not require a second surgical site, and provides a graft of adequate dimensions.

Study Overview

• Status: Not yet recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: SCTG followed by coronally postionting flap; Procedure: periosteal flap followed by coronally postionting flap

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with one or more Miller's Class 1 and Class II buccal recessions demonstrating ≤20% of plaque and bleeding scores, respectively, after Phase I therapy.
• age from 18 th 60 years.

Exclusion Criteria:

• Smokers
• patients with malposed or crowded teeth
• pregnant and lactating women
• patients using medications that could affect the periodontal status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subepothelial connective tissue graft (SCTG) group; Subepithelial connective tissue graft from palate then coronally positioning flap to cover root recession	Procedure: SCTG followed by coronally postionting flap; The SCTG will be harvested from the palate followed by coronally postionting flap
Active Comparator: Periosteal pedicle flap (PPF) group; periosteal flap elevation and repositioning to the root then coronally positioning flap to cover root recession	Procedure: periosteal flap followed by coronally postionting flap; he periosteal pedicle graft obtained is then turned over the exposed root surface then followed by coronally postionting flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of root coverage (%RC)	to measure the coverage percentage of root recession by UNC periodontal probe Preoperative recession depth - Postoperative recession depth /Preoperative recession depth x 100	at base line, 1 month and 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recession depth	to measure vertical recession by UNC periodontal probe from cemento-enamel junction (CEJ) to the gingival margin.	at base line, 1 month and 3 months after treatment
recession width	to measure horizontal recession by UNC periodontal probe the distance between the CEJ and the gingival margin	at base line, 1 month and 3 months after treatment
clinical attachment gain	to measure the periodontal attachment gain after treatment by UNC periodontal probe subtracting the sulcus depth from the distance between the free gingival margin and the mucogingival junction.	at base line, 1 month and 3 months after treatment
keratinized tissue gain	measure the gain in keratinized gingivaby UNC periodontal probe from the most apical point of the gingival margin to the mucogingival junction (MGJ) at the middle buccal point.	at base line, 1 month and 3 months after treatment

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: periosteal pedicle flap

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No