Recruiting

CAF & GPST

Sponsor:

Case Western Reserve University

Code:

NCT06037161

Conditions

Recession, Gingival

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mandibular Incisor root coverage procedure

Study Details

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

Study ID

NCT06037161

Start date

May 19, 2023

Status verified date

May, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GPST + CTG

Gingival Pedicle Split Thickness + Connective Tissue Graft procedure

active comparator: CAF + CTG

Coronally Advanced Flap + Connective Tissue Graft procedure

Interventions

Mandibular Incisor root coverage procedure

Mucogingival procedure to cover mandibular incisor tooth with receded gums

Primary outcome measure

  • Percentage of mean root coverage [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Gian Pietro Schincaglia, DDS,PhD

2163684412gxs486@case.edu

Clara Sous

2163684412cms395@case.edu

Locations

Case Western Reserve University School of Dental Medicine

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Gian Schincaglia

gxs486@case.edu

Clara Sous

2162006971cms395@case.edu

More Information

Sponsor

Case Western Reserve University

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-05-20.