Evaluation of Geistlich Fibro-Gide® + CAF in Comparison to CTG + CAF for the Treatment of Recession Defects at 6 Months
Completed · Not applicable
Conditions studied: Gingival Recession
In brief
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.
Key facts
- Study ID
- NCT04260152
- Run by
- Geistlich Pharma AG
- People needed
- 30
- Starts
- 2018-09-01
- Expected to finish
- 2020-07-22
- Last updated by the study team
- 2021-08-10
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 to 75 years of age, inclusive.
- Subjects must have at least two teeth with buccal Miller Class I or II recession type defects, 3 mm deep and 3 mm wide on the same tooth in the contralateral quadrant of the same jaw
- Defects should be similar in size and morphology
- Teeth with root canals should be asymptomatic, completed at least 6 months prior
- At least 1mm KT
- Subjects with parafunctional habits must wear a bite guard to be included.
You may not qualify if…
- Participation within the previous 30 days in other investigational clinical trials.
- Class V restorations or abfractions that obliterate the CEJ.
- Subjects whose teeth have extremely prominent root surfaces -greater than 2mm facially to the adjacent teeth measured at the level of the CEJ.
- Systemic conditions that could influence wound healing or any other conditions that would preclude periodontal surgery.
- Taking medications that compromise wound healing.
- Acute infectious lesions in the areas intended for surgery.
- Untreated moderate to severe periodontal disease.
- Weekly or more frequent use of nicotine products within the past 6 months.
- Females who are pregnant or lactating, or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control.
- Subjects who require sedation in order to undergo surgery.
- Molars, teeth with axial mobility or interproximal loss of attachment, or full coverage crowns or veneers do not qualify.
Where it is running
- Seven Lakes Periodontitis — Fenton, Michigan, United States
- Perio Health Professionals — Houston, Texas, United States
- Oral Health Specialists — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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