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

NCT06435780 | Recruiting

• 1 other identifier: FWA #00022887
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Defect in Alveolar Ridge

Keywords

ridge contour defect; soft tissue graft; Rolling Technique; Connective tissue graft; Subepithelial palatal graft; Seibert Class I

Outcome Measures

Primary Outcomes (1)

• Ridge contour thickness gain

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

  6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Procedure: DIPRF

Control group

ACTIVE COMPARATOR

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

Procedure: DIPRF

Interventions

DIPRF PROCEDURE

Denuded interpositional pedicled rolled flap technique

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International University

Cairo, Egypt

RECRUITING

Related Publications (18)

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  PMID: 1343013 BACKGROUND

• Su H, Gonzalez-Martin O, Weisgold A, Lee E. Considerations of implant abutment and crown contour: critical contour and subcritical contour. Int J Periodontics Restorative Dent. 2010 Aug;30(4):335-43.

  PMID: 20664835 BACKGROUND

• Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part I. Technique and wound healing. Compend Contin Educ Dent (Lawrenceville). 1983 Sep-Oct;4(5):437-53. No abstract available.

  PMID: 6578906 BACKGROUND

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  PMID: 287786 BACKGROUND

• Langer B, Calagna L. The subepithelial connective tissue graft. J Prosthet Dent. 1980 Oct;44(4):363-7. doi: 10.1016/0022-3913(80)90090-6.

  PMID: 6931898 BACKGROUND

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  PMID: 6950973 BACKGROUND

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  PMID: 6950860 BACKGROUND

• Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.

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• Soehren SE, Allen AL, Cutright DE, Seibert JS. Clinical and histologic studies of donor tissues utilized for free grafts of masticatory mucosa. J Periodontol. 1973 Dec;44(12):727-41. doi: 10.1902/jop.1973.44.12.727. No abstract available.

  PMID: 4586681 BACKGROUND

• Akcali A, Schneider D, Unlu F, Bicakci N, Kose T, Hammerle CH. Soft tissue augmentation of ridge defects in the maxillary anterior area using two different methods: a randomized controlled clinical trial. Clin Oral Implants Res. 2015 Jun;26(6):688-95. doi: 10.1111/clr.12368. Epub 2014 Apr 10.

  PMID: 24720375 BACKGROUND

• Mormann W, Schaer F, Firestone AR. The relationship between success of free gingival grafts and transplant thickness. Revascularization and shrinkage--a one year clinical study. J Periodontol. 1981 Feb;52(2):74-80. doi: 10.1902/jop.1981.52.2.74.

  PMID: 6164778 BACKGROUND

• Studer SP, Lehner C, Bucher A, Scharer P. Soft tissue correction of a single-tooth pontic space: a comparative quantitative volume assessment. J Prosthet Dent. 2000 Apr;83(4):402-11. doi: 10.1016/s0022-3913(00)70034-5.

  PMID: 10756289 BACKGROUND

• Thoma DS, Benic GI, Zwahlen M, Hammerle CH, Jung RE. A systematic review assessing soft tissue augmentation techniques. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:146-65. doi: 10.1111/j.1600-0501.2009.01784.x.

  PMID: 19663961 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Gurlek O, Sonmez S, Guneri P, Nizam N. A novel soft tissue thickness measuring method using cone beam computed tomography. J Esthet Restor Dent. 2018 Nov;30(6):516-522. doi: 10.1111/jerd.12428. Epub 2018 Nov 15.

  PMID: 30444040 BACKGROUND

• Das G, Ahmed AR, Suleman G, Lal A, Rana MH, Ahmed N, Arora S. A Comparative Evaluation of Dentogingival Tissue Using Transgingival Probing and Cone-Beam Computed Tomography. Medicina (Kaunas). 2022 Sep 19;58(9):1312. doi: 10.3390/medicina58091312.

  PMID: 36143989 BACKGROUND

• Smeets EC, de Jong KJ, Abraham-Inpijn L. Detecting the medically compromised patient in dentistry by means of the medical risk-related history. A survey of 29,424 dental patients in The Netherlands. Prev Med. 1998 Jul-Aug;27(4):530-5. doi: 10.1006/pmed.1998.0285.

  PMID: 9672946 BACKGROUND

• Ammar AH, Ahmed E, ElBarbary A, Ghalwash D, Ezz Elarab A. Clinical Comparison of the Volumetric Changes in Single Pontic Site Development through Connective Tissue Grafting Using Modified Pouch Technique versus Pouch Technique in the Maxillary Esthetic Zone: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Aug 25;2022:1677471. doi: 10.1155/2022/1677471. eCollection 2022.

  PMID: 36059913 BACKGROUND

Study Officials

• Hebattallah A Mattar

  Misr International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hebattallah A Mattar

CONTACT

201207000253; hebatullah.mater@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director of International Implantology Program (IIP)

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: May 30, 2024
• Study Start: April 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

EG (1)