Comparison of Two Methods of Covering a Single Lower Front Tooth With Receded Gums

NCT06037161 | Recruiting

• 1 other identifier: STUDY20220902
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this randomized clinical trial is to compare the mean root coverage achieved with Coronally Advanced Flap (CAF) + Connective Tissue Graft (CTG) (control) to Gingival Pedicle Split Thickness flap (GPST) + CTG (test) for the treatment of isolated gingival recession defects in mandibular incisors. The secondary objectives are to compare the percentage of complete root coverage and keratinized tissue gain between the two techniques.

Conditions

Recession, Gingival

Keywords

Connective tissue graft(s); cosmetic periodontal plastic surgery; gingival recession; mucogingival surgery; treatment planning

Outcome Measures

Primary Outcomes (1)

• Percentage of mean root coverage

  The mean of the amount of root coverage will be calculated within and between test and control groups.

  6 months

Secondary Outcomes (2)

• Percentage of complete root coverage

  6 months

• Keratinized Tissue gain.

  6 months

Study Arms (2)

GPST + CTG

EXPERIMENTAL

Gingival Pedicle Split Thickness + Connective Tissue Graft procedure

Procedure: Mandibular Incisor root coverage procedure

CAF + CTG

ACTIVE COMPARATOR

Coronally Advanced Flap + Connective Tissue Graft procedure

Procedure: Mandibular Incisor root coverage procedure

Interventions

Mandibular Incisor root coverage procedure PROCEDURE

Mucogingival procedure to cover mandibular incisor tooth with receded gums

CAF + CTG; GPST + CTG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females of \> 18 years of age
• Single Cairo's RT1 (Recession Type 1) and RT2 ( Recession Type 2) recession defects (≥3 mm in depth) in mandibular anterior teeth (Incisors).
• Presence of identifiable cemento-enamel junction (CEJ)
• Presence of a step ≤1 mm at the CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ, will be accepted
• Periodontally and systemically healthy patients
• No contraindications for periodontal surgery and not taking medications known to interfere with periodontal tissue health or healing; and no prior periodontal surgery on the involved sites

You may not qualify if:

• Vaping, chewing tobacco or smoking \> 10 cigarettes per day
• Uncontrolled Diabetes Mellitus (HbA1c \> 7)
• Pregnancy and Lactation
• Diseases affecting connective tissue metabolism
• Long-term steroid use
• Recession defects associated with caries
• Teeth associated with pulpal pathology

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University School of Dental Medicine

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Gian Pietro Schincaglia, DDS, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Pietro Schincaglia, DDS,PhD

CONTACT

2163684412; gxs486@case.edu

Clara Sous

CONTACT

2163684412; cms395@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chair and Graduate Program Director

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 14, 2023
• Study Start: May 19, 2023
• Primary Completion: January 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)