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Active, not recruiting Not applicable

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

NCT07577193 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-10-01
Last updated
2026-05-11

Condition(s) studied

Soft Tissue Atrophy

Investigational drug(s) / intervention(s)

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).

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.

Study 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.

Eligibility

Sex
ALL
Min age
25 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Clinical Evaluation: — 3 months
    Wound Healing Status: Presence or absence of soft tissue dehiscence or wound infection. Unit: Yes/No. Time Frame: Post-operative follow-up visits.
  • clinical — 3 months
    Implant Stability: Implant stability measured using Resonance Frequency Analysis (Osstell). Unit: Implant Stability Quotient (ISQ). Time Frame: Immediately post-placement and at 3 months.
  • Clinical — 3 months
    Surgical Operation Time: Duration of implant site preparation and graft fixation. Unit: Minutes. Time Frame: During surgery.
  • clinical — 3 months
    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.

Trial sites (1)

FacilityCityRegionStatus
faculty of dentistry Mansoura university, Mansoura, 35516 Al Mansurah Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07577193 on ClinicalTrials.gov ↗ ← All trials in Egypt