Comparison of Two Methods of Covering a Single Lower Front Tooth With Receded Gums
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ClinicalTrials.gov Identifier: NCT06037161 |
Recruitment Status :
Recruiting
First Posted : September 14, 2023
Last Update Posted : September 14, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recession, Gingival | Procedure: Mandibular Incisor root coverage procedure | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Surgical Techniques to Treat Isolated Gingival Recession in Mandibular Incisors: A Randomized Clinical Trial |
Actual Study Start Date : | May 19, 2023 |
Estimated Primary Completion Date : | January 30, 2025 |
Estimated Study Completion Date : | July 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: GPST + CTG
Gingival Pedicle Split Thickness + Connective Tissue Graft procedure
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Procedure: Mandibular Incisor root coverage procedure
Mucogingival procedure to cover mandibular incisor tooth with receded gums |
Active Comparator: CAF + CTG
Coronally Advanced Flap + Connective Tissue Graft procedure
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Procedure: Mandibular Incisor root coverage procedure
Mucogingival procedure to cover mandibular incisor tooth with receded gums |
- Percentage of mean root coverage [ Time Frame: 6 months ]The mean of the amount of root coverage will be calculated within and between test and control groups.
- Percentage of complete root coverage [ Time Frame: 6 months ]The percentage of teeth that achieved complete root coverage will be compared between test and control.
- Keratinized Tissue gain. [ Time Frame: 6 months ]The changes in the amount of keratinized tissue from baseline to 6 months will calculated within and between study groups
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06037161
Contact: Gian Pietro Schincaglia, DDS,PhD | 2163684412 | gxs486@case.edu | |
Contact: Clara Sous | 2163684412 | cms395@case.edu |
United States, Ohio | |
Case Western Reserve University School of Dental Medicine | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Gian Schincaglia gxs486@case.edu | |
Contact: Clara Sous 2162006971 cms395@case.edu |
Principal Investigator: | Gian Pietro Schincaglia, DDS, PhD | Case Western Reserve University |
Responsible Party: | Gian Schincaglia, Professor, Chair and Graduate Program Director, Case Western Reserve University |
ClinicalTrials.gov Identifier: | NCT06037161 |
Other Study ID Numbers: |
STUDY20220902 |
First Posted: | September 14, 2023 Key Record Dates |
Last Update Posted: | September 14, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Connective tissue graft(s) cosmetic periodontal plastic surgery gingival recession mucogingival surgery treatment planning |
Gingival Recession Gingival Diseases Periodontal Diseases |
Mouth Diseases Stomatognathic Diseases Periodontal Atrophy |