Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects

Misr International University

Status: Enrolling

Conditions: Defect in Alveolar Ridge

Treatments: Procedure: DIPRF

Study type: Interventional

Funder types: Other

Identifiers

NCT06435780

FWA #00022887

Details and patient eligibility

About

The aim of the study is to clinically and radiographically evaluate and compare two techniques to augment soft tissues: the conventional subepithelial connective tissue graft technique and a novel denuded interpositional pedicled rolled flap technique (DIPRF) These techniques will be used to augment edentulous ridges that are recommended for rehabilitation by an implant or a fixed restoration.

Full description

Fifty patients with soft tissue ridge contour defects in the maxillary premolar region and recommended for rehabilitation by an implant or a fixed restoration will be enrolled. Patients will be allocated randomly into two groups; group 1 (test group) will have augmentation for their soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF); group 2 (control group) will be augmented by the conventional subepithelial connective tissue graft technique. Clinical volumetric change evaluation and ridge thickness analysis using digitally calibrated casts and CBCT analysis with a fusion software will be performed for every site as well as periodontal evaluation and patient centered outcomes, including pain and satisfaction after the procedure will be recorded for both techniques. For each site, an impression will be used to pour a cast that will be digitally scanned and vertical and horizontal ridge contours dimensions(tissue volumetric changes) will be recorded. These measurements will be obtained before the surgical procedure, 2 weeks, and 3 and 6 months post-surgical. CBCT analysis will be performed pre-operatively to confirm the diagnosis and eligibility of the case as having only soft tissue defect without bone defects, and 6 months postoperatively to analyze the amount of soft tissue gain in the two groups.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults above the age of 18 to 50 years.
2. Males and females as confirmed by asking the female patients about whether they are pregnant or not
3. Patient's with Seibert classification class I requiring future rehabilitation of one or more premolar region and sound adjacent teeth.
4. Soft tissue thickness on the palatal tissues more than 6mm at the site of harvesting the graft.
5. Presence of Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
6. Clinically healthy soft tissues with no signs of clinical pathology of the soft tissue.
7. Good oral hygiene.
8. Patient accepts to sign an informed consent.
9. ASA I or ASA II Patient.

Exclusion criteria

1. Patients with ridge defects due to bone defect
2. Smoker patients who smoke more than 10 cigarettes per day
3. Pregnant females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Experimental group

Experimental group

Description:

Augmentation for their soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF)

Treatment:

Procedure: DIPRF

Control group

Active Comparator group

Description:

Will be augmented by the conventional subepithelial connective tissue graft technique.

Treatment:

Procedure: DIPRF