NCT06037161 Comparison of Two Methods of Covering a Single Lower Front Tooth With Receded Gums
| NCT ID | NCT06037161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Western Reserve University |
| Condition | Recession, Gingival |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-05-19 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2023-05-19 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Gian Pietro Schincaglia, DDS, PhD
PRINCIPAL INVESTIGATOR
Case Western Reserve University
Frequently Asked Questions
Who can join the NCT06037161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Recession, Gingival. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06037161 currently recruiting?
Yes, NCT06037161 is actively recruiting participants. Contact the research team at gxs486@case.edu for enrollment information.
Where is the NCT06037161 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06037161 clinical trial?
NCT06037161 is sponsored by Case Western Reserve University. The principal investigator is Gian Pietro Schincaglia, DDS, PhD at Case Western Reserve University. The trial plans to enroll 36 participants.