Enhancing Soft Tissues Around Inserted Implants by Two Different Methods

NCT06837688 | Recruiting DMC

• 1 other identifier: UDDS-Perio-01-2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial investigates the efficacy of xenogeneic collagen matrix (XCM) versus autogenous subepithelial connective tissue graft (SCTG) in enhancing the peri-implant soft tissue profile around single dental implants in the aesthetic zone of the anterior maxilla. Thirty adult patients with a single missing tooth, adequate bone volume, and sufficient keratinized tissue will be recruited at Damascus University. Each patient will undergo a fully digital workflow for implant planning-including CBCT imaging, intraoral scanning, and CAD/CAM fabrication of a surgical guide and provisional restoration-to ensure precision in implant placement. Immediately following implant insertion, patients will be randomly allocated (1:1) to either receive a CTG harvested from the palatal mucosa using a single incision technique or an XCM (Mucoderm®, Botiss Biomaterials) that is adapted and secured to the buccal mucosa. The primary outcome is the increase in buccal soft tissue profile, measured via superimposed digital surface models at baseline, immediately postoperatively, and at 3 months. Secondary outcomes include patient-reported measures (pain, edema, aesthetic satisfaction), clinical parameters (keratinized tissue width, soft tissue height), peri-implant health assessments, and radiographic assessment. By comparing these two methods, the study aims to determine whether the less invasive XCM can offer outcomes comparable to the CTG standard while reducing donor site morbidity and overall surgical time.

Conditions

Missing Teeth

Keywords

Peri-implant soft tissue augmentation; Xenogeneic collagen matrix; Connective tissue graft

Outcome Measures

Primary Outcomes (1)

• Increase in Buccal Soft Tissue Profile (BSP)

  he BSP is defined as the volumetric change in the buccal soft tissue at the dental implant site. This outcome reflects both the thickness and contour improvements following soft tissue augmentation. Intraoral scans will be taken at three critical time points: preoperatively (T0), immediately postoperatively (T1), and 3 months postoperatively (T2). Digital surface models will be generated from these scans using specialized analysis software. The increase in BSP will be quantified as the difference in soft tissue volume (or thickness, depending on the analysis protocol) between the baseline (T0) and the 3-month follow-up (T2). Graft shrinkage will be measured between the scans immediately postoperatively (T1) and the 3-month follow-up (T2). his is a continuous variable measured in cubic millimeters (mm³) if volumetric data is used, or in millimeters (mm) if linear thickness is the chosen metric.

  T0: Preoperative baseline. T1: Immediately after surgery. T2: 3 months postoperatively

Secondary Outcomes (14)

• Probing Depth (PD)

  Baseline (Preoperative), 3 months, and 6 months postoperatively

• Plaque Index (PI)

  Baseline (Preoperative), 3 months, and 6 months postoperatively.

• Bleeding on Probing (BOP)

  Baseline (Preoperative), 3 months, and 6 months postoperatively

• Graft Dimensions

  Recorded intraoperatively.

• Wound Closure

  Recorded intraoperatively.

Study Arms (2)

Connective tissue graft group

ACTIVE COMPARATOR

Patients receive soft tissue augmentation using an autogenous connective tissue graft. A full-thickness flap is elevated at the implant site, and after implant placement, a CTG is harvested from the palatal mucosa. The graft is then trimmed to the defect dimensions and positioned under the flap to augment the peri-implant soft tissue. The donor site is sutured with double-cross sutures to ensure proper healing

Procedure: Peri-implant soft tissue augmentation using connective tissue graft

Xenogeneic collagen matrix group

EXPERIMENTAL

Patients receive soft tissue augmentation using a xenogeneic collagen matrix (Mucoderm®). After implant placement and flap elevation, the XCM, initially sized at 15 × 20 mm, is moistened in saline for 10 minutes and slightly compressed. It is then adapted to the recipient site following a superficial incision to release muscle tension and secured to the buccal mucosa with single sutures. A screw-retained provisional restoration is installed immediately after surgery to support the augmented tissue.

Procedure: Peri-implant soft tissue augmentation using xenogenic collagen matrix

Interventions

Peri-implant soft tissue augmentation using connective tissue graft PROCEDURE

A full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. A connective tissue graft (CTG) will be harvested from the palatal mucosa using the De-epithelialized free gingival graft technique and tailored to the site dimensions. The graft will be carefully positioned under the elevated flap to augment the soft tissue. The palatal wound will be sutured with double-cross sutures.

Connective tissue graft group

Peri-implant soft tissue augmentation using xenogenic collagen matrix PROCEDURE

A full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. The xenogenic collagen matrix, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures.

Xenogeneic collagen matrix group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 years or older.
• Good oral hygiene, defined as full-mouth plaque score ≤25%.
• Having a single missing tooth in the aesthetic zone of the maxilla.
• Tooth extraction occurred at least 3 months prior to enrolment.
• Having adequate bone volume for implant placement (bucco-palatal bone dimension of at least 6 mm).
• Having at least 5 mm of keratinized tissue width at the implant site.

You may not qualify if:

• Systemic diseases.
• Smoking.
• Periodontal disease.
• Untreated caries lesions.
• Need for horizontal bone augmentation at the time of implant placement.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 00000, Syria

RECRUITING

Related Publications (6)

• Tommasato G, Del Fabbro M, Oliva N, Khijmatgar S, Grusovin MG, Sculean A, Canullo L. Autogenous graft versus collagen matrices for peri-implant soft tissue augmentation. A systematic review and network meta-analysis. Clin Oral Investig. 2024 May 5;28(5):300. doi: 10.1007/s00784-024-05684-5.

  PMID: 38704784 BACKGROUND

• Dadlani S, Joseph B, Anil S. Efficacy of Xenogeneic Collagen Matrices in Augmenting Peri-Implant Soft Tissue: A Systematic Review and Meta-Analysis. Clin Exp Dent Res. 2024 Aug;10(4):e937. doi: 10.1002/cre2.937.

  PMID: 39104130 BACKGROUND

• Hamdy A, Ibrahim SSA, Ghalwash D, Adel-Khattab D. Volumetric assessment of volume stable collagen matrix in maxillary single implant site development: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2024 Oct;26(5):930-941. doi: 10.1111/cid.13353. Epub 2024 Jun 27.

  PMID: 38938060 BACKGROUND

• Surdiacourt L, Christiaens V, De Bruyckere T, De Buyser S, Eghbali A, Vervaeke S, Younes F, Cosyn J. A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 3-Year results. J Clin Periodontol. 2025 Jan;52(1):92-101. doi: 10.1111/jcpe.13975. Epub 2024 Mar 14.

  PMID: 38485651 BACKGROUND

• Eeckhout C, Vuylsteke F, Seyssens L, Christiaens V, De Bruyckere T, Eghbali A, Vervaeke S, Younes F, Cosyn J. A Multi-Centre Randomized Controlled Trial Comparing Connective Tissue Graft with Collagen Matrix to Increase Buccal Soft Tissue Thickness: A Cone-Beam CT Analysis. J Clin Med. 2023 Apr 19;12(8):2977. doi: 10.3390/jcm12082977.

  PMID: 37109311 BACKGROUND

• Cosyn J, Eeckhout C, Christiaens V, Eghbali A, Vervaeke S, Younes F, De Bruyckere T. A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 3-month results. J Clin Periodontol. 2021 Dec;48(12):1502-1515. doi: 10.1111/jcpe.13560. Epub 2021 Oct 12.

  PMID: 34605057 BACKGROUND

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Suleiman Dayoub, DDS MSc PhD

  Damarcus University

  STUDY DIRECTOR

• Ali Omair, DDS

  Damarcus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Omair, DDS

CONTACT

+963992964458; ali.omair.formal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After screening and obtaining informed consent, patients are randomly allocated into one of the two intervention groups (CTG or XCM) in a 1:1 ratio using a permuted block randomization method with block sizes of 4 and 6. The allocation sequence, generated by an independent statistician, is secured in sequentially numbered, opaque envelopes and is revealed at the time of surgery to assign the appropriate intervention. Our study is designed as a single-blinded trial. The outcome assessors and data analysts will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)