- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06366022
Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft
Study Overview
Status
Conditions
Detailed Description
Condition or disease:Multiple Gingival Recession
Intervention/treatment:
Device: Modified coronally advanced tunnel with connective tissue graft placed with inner side towards the flap Device: Modified coronally advanced tunnel with subepithelial connective tissue graft with the outer side towards the flap Phase :Not Applicable
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
MAzowsze
-
Warsaw, MAzowsze, Poland, 00-246
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- Bilateral multiple gingival recessions in homologous teeth in the same arch.
Exclusion Criteria:
- Full-mouth plaque index ≥ 20% (Ainamo & Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann & Son 1971)
- Smoking
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
- Pregnant and lactating females
- Previous periodontal surgery in the area
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: The tunnel technique for root coverage with CTG with outer side of the graft
Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study |
Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG).
A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions.
The CTG will be inserted into the tunnel and positioned so that the outer side of the graft faces the inner surface of the flap.
The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.
|
|
Experimental: The tunnel technique for root coverage with CTG with inner side of the graft
Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study. |
Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG).
A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions.
The CTG will be inserted into the tunnel and positioned so that the inner (deep) side of the graft faces the inner surface of the flap (standardized graft orientation).
The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Change in Gingival Recession (Mean Root Coverage, MRC)
Time Frame: Baseline and 6 months after surgery
|
Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%.
|
Baseline and 6 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
Time Frame: 6 months after surgery
|
The analyzed metrics were calculated as follows: GR change= GR0-GR6 (after 6 months); ) [millimetre] higher scores mean better outcome GT change = GT6-GT0 (after 6 months); [millimetre] higher scores mean better outcome KTW change = KTW6-KTW0 (after 6 months); [millimetre] higher scores mean better outcome
|
6 months after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Root Coverage Esthetic Score (RES)
Time Frame: 6 months after surgery
|
RES:The following variables were assessed:
|
6 months after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bartłomiej Górski, PhD, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Warsaw.06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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