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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Soft Tissue Atrophy
• Intervention / Treatment: 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).

Detailed Description

Therefore, the primary objective is to evaluate the integration of porcine collagen matrix with the recipient site and measuring the amount gained of keratinized mucosa. The secondary objective is to assess the pink esthetic score around dental implant following porcine collagen matrix compared to the free gingiva graft.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Mansurah, Egypt
    • faculty of dentistry Mansoura university, Mansoura, 35516

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dental implant with application of free gingival graft; 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).; 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.
Experimental: dental implants with application of porcine collagen matrix; 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).; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical periodontal parameters	Plaque Index (PI): Dental plaque accumulation around implants measured using the Plaque Index. Unit: PI score. Time Frame: 3 months post-operatively.	3 months
radiographic	Implant Position AccuracyDescription:Evaluation of the accuracy of dental implant placement in relation to adjacent teeth and surrounding vital anatomical structures using Cone Beam Computed Tomography (CBCT).Unit of Measure:Deviation distance in millimeters (mm)Time Frame:At 6 months post-implant placement; Crestal Bone Level Changes - MesiodistalDescription:Measurement of crestal bone level changes in the mesiodistal direction around the dental implant using CBCT.Unit of Measure:Millimeters (mm)Time Frame:At 6 months post-implant placement; Crestal Bone Level Changes - Buccolingual Description: Measurement of crestal bone level changes in the buccolingual direction around the dental implant using CBCT. Unit of Measure: Millimeters (mm) Time Frame: At 6 months post-implant placement	6 months
clinical parameters	Probing Depth (PD): Peri-implant probing depth to assess peri-implant tissue health. Unit: mm. Time Frame: 3 months post-operatively.	3 months
clinical perodontal parameters	Clinical Attachment Level (CAL): Measurement from cemento-enamel junction to base of peri-implant sulcus/pocket. Unit: mm. Time Frame: 3 months post-operatively.	3 months
clinical periodontal parameters	Keratinized Tissue Width (KTW): Width of keratinized mucosa around implant site. Unit: mm. Time Frame: 3 months post-operatively.	3 months
clinical periodontal parameters	Gingival Thickness (GT): Thickness of peri-implant gingiva. Unit: mm. Time Frame: 3 months post-operatively.	3 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: mohamad sa haichal, bachelor, Faculty of Dentistry Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: A0101025 OM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No