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

N/AActive Not RecruitingNCT07577193

Mansoura University20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Soft Tissue Atrophy

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

faculty of dentistry Mansoura university, Mansoura, 35516

Al Mansurah, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 3 months

Clinical

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

Time frame: 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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

radiographic

1. Implant Position Accuracy Description: 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 2. Crestal Bone Level Changes - Mesiodistal Description: 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 3. 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

Data from ClinicalTrials.gov

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