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NCT Number: NCT06435780

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Misr International University

Cairo, Egypt

Location status: Recruiting

Location contact

Maqhassen M Farghaly, Professor

CONTACT

[email protected]

201006708522

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

DIPRF

Procedure

Denuded interpositional pedicled rolled flap technique

Primary outcomes

  1. Ridge contour thickness gain

    Time frame: 6 months

    Ridge contour will be assessed using CBCT analysis using fusion software. The differences between measurement times will indicate the amount of bone gain

Study contacts

Contact information is provided by the study sponsor or research team.

Hebattallah A Mattar

CONTACT

[email protected]

201207000253

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

Evaluation of a Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects. A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 30, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.