Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID06837688

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

Led by Damascus University · Updated on 2025-03-05

30

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two methods to improve soft tissue around single dental implants in the front upper jaw area, focusing on people missing one tooth with enough bone and gum tissue. The study compares a traditional connective tissue graft (CTG) taken from the patient's palate with a less invasive xenogeneic collagen matrix (XCM) to see if XCM can offer similar results while reducing surgery time and donor site discomfort. This trial is randomized and controlled, aiming to enhance implant esthetics and function with fewer complications. Participants undergo detailed digital planning using CBCT scans and intraoral scans to precisely place the dental implant with a surgical guide. After implant placement, they are randomly assigned to receive either the CTG harvested from the palate or the XCM graft applied to the gum. The CTG involves a second surgical site to collect tissue, while the XCM is prepared by moistening and adapting it before securing it to the gum. Both groups receive a screw-retained provisional restoration immediately after surgery to support healing and appearance. During the study, participants will have assessments at baseline, immediately after surgery, and at 3 months to measure soft tissue changes using digital models. Additional evaluations include gum health, bone loss via X-rays, patient pain and swelling reports, aesthetic satisfaction, and surgery time. Follow-up visits extend to 6 months to monitor healing, complications, and tissue condition. The study collects detailed clinical and patient-reported data to compare outcomes and guide future implant treatments.

CONDITIONS

Brief Title

Enhancing Soft Tissues Around Inserted Implants by Two Different Methods

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Good oral hygiene, with full-mouth plaque score less than or equal to 25%
  • Having a single missing tooth in the aesthetic zone of the upper jaw
  • Tooth extraction occurred at least 3 months prior to enrollment
  • Adequate bone volume for implant placement (bucco-palatal bone dimension of at least 6 mm)
  • At least 5 mm of keratinized tissue width at the implant site
Not Eligible

You will not qualify if you...

  • Presence of systemic diseases
  • Smoking
  • Periodontal (gum) disease
  • Untreated cavities
  • Need for horizontal bone augmentation at implant placement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) including clinical and radiographic examinations

Treatment

Duration - Single day surgical procedure with immediate provisional restoration

Participants undergo dental implant placement and soft tissue augmentation using either a connective tissue graft or a xenogeneic collagen matrix. A full-thickness flap is elevated, the implant is placed using a surgical guide, and the soft tissue is augmented accordingly. A provisional restoration is attached immediately after surgery.

1 surgical visit (in-person)

Follow-up

Duration - 6 months

Participants attend follow-up visits to assess healing, soft tissue profile, clinical outcomes, aesthetic satisfaction, and complications up to 6 months after surgery.

Visits at 1 week, 3 months, and 6 months postoperatively

Trial Site Locations

Total: 1 location

1

Damascus University

Damascus, Syria, 00000

Actively Recruiting

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Research Team

A

Ali Omair, DDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Autogenous graft versus collagen matrices for peri-implant soft tissue augmentation. A systematic review and network meta-analysis.

Grazia Tommasato, Massimo Del Fabbro, Nadim Oliva...

https://pubmed.ncbi.nlm.nih.gov/38704784

Efficacy of Xenogeneic Collagen Matrices in Augmenting Peri-Implant Soft Tissue: A Systematic Review and Meta-Analysis.

Shashi Dadlani, Betsy Joseph, Sukumaran Anil

https://pubmed.ncbi.nlm.nih.gov/39104130

Volumetric assessment of volume stable collagen matrix in maxillary single implant site development: A randomized controlled clinical trial.

Ahmed Hamdy, Suzan Seif Allah Ibrahim, Dalia Ghalwash...

https://pubmed.ncbi.nlm.nih.gov/38938060

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.

Lenz Surdiacourt, Véronique Christiaens, Thomas De Bruyckere...

https://pubmed.ncbi.nlm.nih.gov/38485651

A Multi-Centre Randomized Controlled Trial Comparing Connective Tissue Graft with Collagen Matrix to Increase Buccal Soft Tissue Thickness: A Cone-Beam CT Analysis.

Célien Eeckhout, Fauve Vuylsteke, Lorenz Seyssens...

https://pubmed.ncbi.nlm.nih.gov/37109311

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.

Jan Cosyn, Célien Eeckhout, Véronique Christiaens...

https://pubmed.ncbi.nlm.nih.gov/34605057