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

NCT ID: NCT06435780

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Defect in Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

DIPRF

Intervention Type PROCEDURE

Denuded interpositional pedicled rolled flap technique

Control group

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

Group Type ACTIVE_COMPARATOR

DIPRF

Intervention Type PROCEDURE

Denuded interpositional pedicled rolled flap technique

Interventions

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DIPRF

Denuded interpositional pedicled rolled flap technique

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Misr International University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abo El Futtouh

Clinical Director of International Implantology Program (IIP)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hebattallah A Mattar

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Locations

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Misr International University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hebattallah A Mattar

Role: CONTACT

201207000253

Facility Contacts

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Maqhassen M Farghaly, Professor

Role: primary

201006708522

References

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Scharf DR, Tarnow DP. Modified roll technique for localized alveolar ridge augmentation. Int J Periodontics Restorative Dent. 1992;12(5):415-25.

Reference Type BACKGROUND
PMID: 1343013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20664835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6578906 (View on PubMed)

Meltzer JA. Edentulous area tissue graft correction of an esthetic defect. A case report. J Periodontol. 1979 Jun;50(6):320-2. doi: 10.1902/jop.1979.50.6.320.

Reference Type BACKGROUND
PMID: 287786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6931898 (View on PubMed)

Kaldahl WB, Tussing GJ, Wentz FM, Walker JA. Achieving an esthetic appearance with a fixed prosthesis by submucosal grafts. J Am Dent Assoc. 1982 Apr;104(4):449-52. doi: 10.14219/jada.archive.1982.0209.

Reference Type BACKGROUND
PMID: 6950973 (View on PubMed)

Garber DA, Rosenberg ES. The edentulous ridge in fixed prosthodontics. Compend Contin Educ Dent (Lawrenceville). 1981 Jul-Aug;2(4):212-23. No abstract available.

Reference Type BACKGROUND
PMID: 6950860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6950834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4586681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24720375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6164778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10756289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19663961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30211382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30444040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36143989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9672946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36059913 (View on PubMed)

Other Identifiers

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FWA #00022887

Identifier Type: -

Identifier Source: org_study_id

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