- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07616960
Combined Bilaminar Tunnel Technique in Treating Difficult Gingival Recessions
Effectiveness of the Combined Bilaminar Tunnel Technique in Treating Anatomically Difficult Gingival Recessions: A Prospective Cohort Study
The goal of this clinical trial is to learn if the combined bilaminar tunnel technique works to treat anatomically difficult gingival recessions. It will also explore whether anatomical factors are associated with root coverage outcomes. The main questions it aims to answer are:
Does the combined bilaminar tunnel technique improve root coverage outcomes in patients with anatomically difficult gingival recessions? Are specific anatomical factors associated with root coverage outcomes after the combined bilaminar tunnel technique?
Participants will:
Receive root coverage surgery using the combined bilaminar tunnel technique Visit the clinic for follow-up evaluations after surgery Receive clinical measurements to assess gingival recession and root coverage outcomes Receive radiographic evaluation to assess anatomical characteristics, if clinically indicated or available
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan, 10507
- Chang Gung Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Orthodontic patients who were going to be treated with cTUN approach for soft tissue modification.
- Healthy periodontal condition or well controlled periodontitis with periodontal probing depth ≦ 3mm, and absence of bleeding on probing.
- Thin gingival phenotype, determined with visible metal shade[27]
- Intact clinical and pre-surgery radiographic data (CBCT) was available, and the patient followed the recommended supportive post-surgery treatment at least 6 month after the surgery.
- Informed consent had been obtained prior to the mucogingival surgery.
Exclusion Criteria:
- Uncontrolled systemic disease, such as hypertension, diabetes.
- Untreated periodontitis
- History of radiation therapy on head and neck regions.
- Heavy smokers (more than 0.5 pack per day).
- Patient with pregnancy or breastfeeding.
- History of mucogingival surgery performed on the same site.
- Patient who did not comply to the recommended supportive treatment was regarded as erratic complier.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients who received root coverage surgery with combined bilaminar tunnel technique
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Participants will receive root coverage surgery using the combined bilaminar tunnel technique for the treatment of gingival recession.
The procedure initiates with a partial-thickness flap at the sites with the most severe recession with tunnelled coronally advanced flap(tCAF), extending from the coronal margin to the mucogingival junction (MGJ).
For adjacent teeth, intrasulcular incisions are made to prepare a full-thickness flap using a tunnel knife.
A de-epithelialized connective tissue graft is harvested and stabilized at the coronal portion of the recipient site to facilitate root coverage.
Simultaneously, a volume-stable collagen matrix (VSCM) is placed apically within the partial-thickness flap to fill bone concavities and reduce tissue retraction forces during healing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mean root coverage and complete root coverage rate
Time Frame: From enrollment to six month after receiving the treatment
|
Mean root coverage will be calculated as the percentage reduction in gingival recession depth from baseline to the 6 month after receiving the treatment.
Gingival recession depth will be measured as the distance from the cemento-enamel junction to the gingival margin.
|
From enrollment to six month after receiving the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation Between Clinical and Anatomical Factors and Baseline Recession Depth
Time Frame: perioperative
|
The correlation between clinical and anatomical factors and baseline recession depth will be assessed.
Clinical and anatomical factors will include baseline keratinized tissue width, tooth angulation, depth of alveolar bone concavity, angulation of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness.
Baseline keratinized tissue width and recession depth will be measured clinically in millimeters using a periodontal probe.
Tooth angulation and angulation of alveolar bone concavity will be measured in degrees on CBCT images.
Depth of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness will be measured in millimeters on CBCT images.
The correlation will be evaluated using linear regression analysis.
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perioperative
|
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Correlation Between Clinical and Anatomical Factors and Mean Root Coverage After Treatment with the Combined Bilaminar Tunnel Technique
Time Frame: From baseline to 6 month after treatment.
|
The correlation between clinical and anatomical factors and mean root coverage after treatment will be assessed.
Clinical and anatomical factors will include baseline keratinized tissue width, tooth angulation, depth of alveolar bone concavity, angulation of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness.
Baseline keratinized tissue width will be measured clinically in millimeters using a periodontal probe.
Tooth angulation and angulation of alveolar bone concavity will be measured in degrees on CBCT images.
Depth of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness will be measured in millimeters on CBCT images.
Mean root coverage will be calculated as the percentage reduction in recession depth from baseline to 6 months after treatment.
The correlation will be evaluated using linear regression analysis.
|
From baseline to 6 month after treatment.
|
|
Association Between Clinical and Anatomical Factors and Complete Root Coverage After Treatment
Time Frame: From baseline to 6 month after treatment
|
The association between clinical and anatomical factors and complete root coverage after treatment will be assessed.
Clinical and anatomical factors will include baseline keratinized tissue width, tooth angulation, depth of alveolar bone concavity, angulation of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness.
Baseline keratinized tissue width will be measured clinically in millimeters using a periodontal probe.
Tooth angulation and angulation of alveolar bone concavity will be measured in degrees on CBCT images.
Depth of alveolar bone concavity, root prominence, buccal bone dehiscence, and buccal bone thickness will be measured in millimeters on CBCT images.
Complete root coverage will be recorded as a binary outcome, defined as the presence or absence of complete coverage of the previously exposed root surface at 6 months after treatment.
The association will be evaluated using logistic regression analysis.
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From baseline to 6 month after treatment
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Collaborators and Investigators
Sponsor
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202200265A3D001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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