- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07861724
Effectiveness of Subepithelial Connective Tissue Graft as an Autogenous Barrier Membrane for Hard and Soft Tissue Augmentation in Horizontally Deficient Ridges During Delayed Implant Placement (CBCT-GBR-SECTG)
Clinical Effectiveness of Subepithelial Connective Tissue Graft as an Autogenous Barrier Membrane for Simultaneous Hard and Soft Tissue Augmentation During Delayed Implant Placement in Horizontally Deficient Alveolar Ridges: An Interventional Case Series
This study evaluates the clinical effectiveness of using a patient's own subepithelial connective tissue graft as a natural barrier membrane during simultaneous hard and soft tissue augmentation in areas of the jawbone with insufficient horizontal width. The procedure will be performed during delayed dental implant placement. The study aims to assess changes in hard and soft tissue dimensions and the clinical outcomes of this approach in patients with horizontally deficient alveolar ridges.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Presence of a single missing tooth with both neighboring teeth present
- Patients at least 18 years of age
- Good oral hygiene defined as full-mouth plaque score ≤25% (O'Leary, Drake, & Naylor, 1972)
- Seibert class I defect at the single tooth gap as clinically assessed with buccopalatal bone dimension of at least 4 mm.
- Patients agreeing to follow up period and sign informed consent
Exclusion criteria:
- Pathological lesions (abscess-cyst-acute infection) in the defect site
- Systemic diseases that would interfere with bone metabolism
- Uncontrolled diabetic patients
- Ongoing treatment or a history of recent chemotherapy or radiotherapy
- Poor oral hygiene after hygienic phase (Plaque control record over 30%) or Active periodontal disease
- Smoking (more than 10 cigarettes)
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: Connective Tissue Graft as an Autogenous Barrier Membrane for Hard and Soft Tissue Augmentation
patient received intrasulcular incision, intrasulcular incisions and vertical release incision, full-thickness flap elevation was performed, autogenous bone collection was done from implant site then the implant placed; SCTG was harvested and placed as an autogenous barrier membrane over double layer of bone graft autogenous then Xeno graft followed by suturing |
after local anesthetic injection, patient received intrasulcular incision, intrasulcular incisions and vertical release incisions, full-thickness flap elevation was performed, autogenous bone collection was done from implant site then the implant placed; SCTG was harvested and placed as an autogenous barrier membrane over double layer of bone graft autogenous then Xeno graft followed by suturing |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Horizontal bone gain
Time Frame: Baseline and 6 months after implant placement
|
Change in horizontal alveolar bone width from baseline to 6 months after implant placement, measured in millimeters (mm) using standardized radiographic assessment. |
Baseline and 6 months after implant placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in buccal and crestal soft tissue thickness
Time Frame: baseline and 6 months after implant placement
|
Change in buccal and crestal soft tissue thickness at the implant site from baseline to 6 months after implant placement, measured in millimeters (mm). |
baseline and 6 months after implant placement
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- PER 6-3-2-001
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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