Effectiveness of Xenogenic Collagen Matrix in Modification of Mucosal Phenotype Around Dental Implants

NCT07577193 | Active Not Recruiting

• 1 other identifier: A0101025 OM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study The rationale for conducting the present study is to evaluate the efficacy of porcine collagen matrix in the management of defective width of keratinized mucosa around dental implant.

Conditions

Soft Tissue Atrophy

Outcome Measures

Primary Outcomes (4)

• Clinical Evaluation:

  Wound Healing Status: Presence or absence of soft tissue dehiscence or wound infection. Unit: Yes/No. Time Frame: Post-operative follow-up visits.

  3 months

• clinical

  Implant Stability: Implant stability measured using Resonance Frequency Analysis (Osstell). Unit: Implant Stability Quotient (ISQ). Time Frame: Immediately post-placement and at 3 months.

  3 months

• Clinical

  Surgical Operation Time: Duration of implant site preparation and graft fixation. Unit: Minutes. Time Frame: During surgery.

  3 months

• clinical

  Post-operative Pain Intensity: Patient-reported pain measured using Visual Analogue Scale (VAS). Unit: VAS score (0-10). Time Frame: Day 1, Day 3, and 1 week post-operatively.

  3 months

Secondary Outcomes (6)

• Clinical periodontal parameters

  3 months

• radiographic

  6 months

• clinical parameters

  3 months

• clinical perodontal parameters

  3 months

• clinical periodontal parameters

  3 months

Study Arms (2)

dental implant with application of free gingival graft

EXPERIMENTAL

Group I: will include 10 patients in which participants will receive dental implant with application of free gingival graft which will be taken from the hard palate to increase the width of keratinize gingiva

Procedure: All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).

dental implants with application of porcine collagen matrix

EXPERIMENTAL

Group II: will include 10 patients in which participants will receive dental implants with application of porcine collagen matrix to increase the width of keratinize gingiva.

Procedure: All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).

Interventions

All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II). PROCEDURE

Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture. Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture.

dental implant with application of free gingival graft; dental implants with application of porcine collagen matrix

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient between 25-50 years old.
• Remaining bone height of more than 8 mm, remaining bone width of 6 mm
• Inadequate keratinized soft tissue \<2 mm (13).
• Favorable pattern of occlusion.
• Good oral hygiene.
• Patient ability to comply with the required recall visits.

You may not qualify if:

• Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
• Patients having any uncontrolled systemic disease which could affect bone healing.
• Patients treated with radiotherapy to the head and neck area within the past 12 months.
• Heavy Smokers (more than 20 cigarette per day) according to WHO.
• Inability or unwillingness to return for follow-up visits.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

faculty of dentistry Mansoura university, Mansoura, 35516

Al Mansurah, Egypt

Location

Study Officials

• mohamad sa haichal, bachelor

  faculty of dentistry Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: surgery and give medication

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: May 11, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)