RecruitingNot ApplicableNCT06837688

Enhancing Soft Tissues Around Inserted Implants by Two Different Methods

Evaluation of Xenogeneic Collagen Matrix Versus Connective Tissue Graft to Enhance Soft Tissue Profile Around Single Dental Implants in the Aesthetic Zone


Sponsor

Damascus University

Enrollment

30 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria5

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

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Interventions

PROCEDUREPeri-implant soft tissue augmentation using connective tissue graft

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.

PROCEDUREPeri-implant soft tissue augmentation using xenogenic collagen matrix

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.


Locations(1)

Damascus University

Damascus, Syria

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NCT06837688


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