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NCT Number: NCT07577193

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Soft Tissue Atrophy

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry Mansoura university, Mansoura, 35516

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Clinical Evaluation:

    Time frame: 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.

  2. clinical

    Time frame: 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.

  3. Clinical

    Time frame: 3 months

    Surgical Operation Time: Duration of implant site preparation and graft fixation.

    Unit: Minutes. Time Frame: During surgery.

  4. clinical

    Time frame: 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.

Secondary outcomes

  1. Clinical periodontal parameters

    Time frame: 3 months

    Plaque Index (PI): Dental plaque accumulation around implants measured using the Plaque Index.

    Unit: PI score. Time Frame: 3 months post-operatively.

  2. radiographic

    Time frame: 6 months

    • 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

    • 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

    • 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

  3. clinical parameters

    Time frame: 3 months

    Probing Depth (PD): Peri-implant probing depth to assess peri-implant tissue health.

    Unit: mm. Time Frame: 3 months post-operatively.

  4. clinical perodontal parameters

    Time frame: 3 months

    Clinical Attachment Level (CAL): Measurement from cemento-enamel junction to base of peri-implant sulcus/pocket.

    Unit: mm. Time Frame: 3 months post-operatively.

  5. clinical periodontal parameters

    Time frame: 3 months

    Keratinized Tissue Width (KTW): Width of keratinized mucosa around implant site.

    Unit: mm. Time Frame: 3 months post-operatively.

  6. clinical periodontal parameters

    Time frame: 3 months

    Gingival Thickness (GT): Thickness of peri-implant gingiva. Unit: mm. Time Frame: 3 months post-operatively.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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