Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Alabama at Birmingham

About this trial

This study is to compare the two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English speaking

At least 18 years old

Able to read and understand informed consent document

Patients with teeth/implants lacking keratinized tissue.

Disqualifiers

Non-English speaking

Less than 18 years old

Smokers/tobacco users (>10 cigarettes/day)

Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing

Trial design

Design model

Parallel

Treatments tested in this trial

  • Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)

    Procedure/Surgery

    A horizontal incision is then placed at the middle of residual KT. Two vertical releasing incisions are followed to allow for apical displacement of the flap. The flap will be then elevated with a split-thickness flap beyond the mucogingival junction where it is sutured at this apical position using a mattress (5-0, monocryl) suture. The recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations.

  • Free Gingival graft

    Procedure/Surgery

    Two vertical incisions are made, and a partial thickness flap are designed to provide a firm and immobile periosteal bed. The raised partial thickness flap will be excised. Muscle and unattached connective tissue fibers are thoroughly scraped with a scalpel to prevent graft mobility. Autogenous FGG was harvested with #15C scalpel blade from hard palate at the same side randomly selected to receive the FGG. Donor area was sutured with 5-0 gut sutures. FGG, is placed and stabilized with simple interrupted 5-0 vicryl sutures at recipient site coronal border and horizontal or periosteal anchorage sutures over the graft.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)Experimental treatment 1 intervention
Group B: Free gingival graft.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of soft tissue regenerated

Compare the change in soft tissue quality (attached or keratinized ) between two used soft tissue grafts by superimposing the before and after intraoral scans and the calculating using a software the difference of soft tissue gain between both scans in (mm)

Time frame
From baseline to 12 months
2

Quantity of soft tissue regenerated (Width of Keratinized Tissue)

Using a periodontal probe , the width of keratinized tissue will be measured in (mm) and compared between two grafts used.

Time frame
From baseline to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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