Gingival Recession Treatment Using Two Different Surgical Techniques
Root Coverage Using Tunneling Technique of Xenogenic Collagen Matrix vs. Autologous Connective Tissue as a Treatment of Miller Class Two Gingival Recession (RCT Study)
1 other identifier
interventional
24
1 country
1
Brief Summary
Coronally the advanced flap is considered a predictable treatment of gingival recession but in certain situations, it needs a filler like subperiosteal connective tissue graft (CTG) which is considered as the gold standard treatment approach. This randomized controlled trial compares the clinical benefits and effectiveness of a xenogenic collagen matrix (mucoderm, botiss, dental, Berlin, Germany) as a filler to the subperiosteal connective tissue graft (CTG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedFirst Submitted
Initial submission to the registry
June 21, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedJuly 19, 2021
July 1, 2021
6 months
June 21, 2021
July 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The zone of keratinized gingiva
The distance from the tip of the papilla to the mucogingival junction minus the probing depth measured in mm using graduated periodontal probe.
6 months after the surgery
Secondary Outcomes (4)
Periodontal probing depth
6 months after the surgery
Clinical attachment loss
6 months after the surgery
Gingival recession
6 months after the surgery
Patient satisfaction of the esthetics
6 months
Study Arms (2)
root coverage surgeries using autologous connective tissue for treatment of gingival recession
ACTIVE COMPARATORroot coverage surgeries using tunneling technique of autologous connective tissue as a treatment of Miller class two gingival recession
root coverage surgeries using xenogenic collagen matrix for treatment of gingival recession
EXPERIMENTALroot coverage surgeries using tunneling technique of mucodrm membrane ; xenogeneic collagen matrix as a treatment of Miller class two gingival recession
Interventions
xenogeneic collagen matrix called mucoderm used for root coverage for treatment of gingival recession instead of harvesting from the patients connective tissue
Eligibility Criteria
You may qualify if:
- The selected patients for this study are non-smokers, aged 18-60 years with multiple gingival recession (Miller class 1, or 2.) for more than two adjacent affected teeth with plaque score less than 25%
You may not qualify if:
- Patients with systemic complications, psychological problems, parafunctional habits, or patients presented with Mal-posed teeth, hypermobile teeth, teeth with Miller class 3 gingival recession were excluded from this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 71111111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Periodontology and Oral Implantology-Faculty of Dentistry, Assiut University, Egypt.
Study Record Dates
First Submitted
June 21, 2021
First Posted
July 19, 2021
Study Start
September 1, 2020
Primary Completion
March 1, 2021
Study Completion
June 15, 2021
Last Updated
July 19, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share