What is the mechanism of action of this treatment?

The most common treatments for Peri-implant Mucositis include soft tissue grafting techniques such as Free Gingival Graft (FGG) and Strip Gingival Graft with Acellular Dermal Matrix (SGG+ADM). FGG involves harvesting tissue from the patient's palate and grafting it to the affected area, which increases the amount of keratinized tissue and enhances the stability and health of the peri-implant mucosa. SGG+ADM combines a smaller autogenous tissue strip with an acellular dermal matrix, which serves as a scaffold to promote tissue integration and regeneration. These treatments are crucial for Peri-implant Mucositis patients as they improve the quality and quantity of the mucosal tissue around implants, reducing inflammation and the risk of further complications.

What side effects are associated with this type of intervention?

Common treatments for peri-implant mucositis include soft tissue grafting techniques such as Free Gingival Graft (FGG) and Strip Gingival Graft with Acellular Dermal Matrix (SGG+ADM). Known side effects of these treatments can include pain, swelling, and discomfort at both the donor and recipient sites. There is also a risk of infection, delayed healing, and graft failure. Additionally, patients may experience temporary changes in sensation or numbness in the treated area.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments of Peri-implant Mucositis that directly align with the soft tissue grafting techniques mentioned (Autogenous Graft vs. Strip Gingival Graft with Acellular Dermal Matrix). Generally, treatments for Peri-implant Mucositis focus on non-surgical approaches such as mechanical debridement, antimicrobial therapy, and improved oral hygiene. However, soft tissue grafting techniques, including the use of autogenous grafts and acellular dermal matrices, are well-established in periodontal and implant dentistry for enhancing keratinized tissue around implants, although specific FDA approvals for these exact methods in the context of Peri-implant Mucositis are not detailed.

What other types of research exist?

Promising novel alternatives to soft tissue grafting for peri-implant mucositis include the use of injectable soft tissue fillers such as hyaluronic acid and calcium hydroxylapatite, which have shown effectiveness in enhancing tissue volume and quality. Additionally, low-level laser therapy (LLLT) and autologous platelet concentrates (APC) are emerging as adjunctive treatments that promote healing and improve tissue health. These alternatives offer less invasive options with potential benefits in tissue regeneration and inflammation control.

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Grafting

Gingival Grafting Techniques for Gum Recession

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years old

Patients with teeth/implants lacking keratinized tissue

Must not have

Previous soft tissue grafting at the site(s) to be treated

Presence of active periodontal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12 months

Awards & highlights

Summary

This trial compares two methods to improve gum tissue quality in patients who lack Keratinized Tissue (KT). One method uses a piece of the patient's own gum tissue, while the other combines a small strip of gum tissue with a special growth-promoting material. The study aims to see which method is better for increasing tissue thickness, improving aesthetics, and minimizing patient discomfort.

Who is the study for?

This trial is for patients at the UAB Dental School, over 18 years old, who can understand consent forms and speak English. They should have healthy teeth or implants next to areas lacking keratinized tissue but no active gum disease, previous grafts in those areas, systemic conditions affecting healing, or heavy tobacco use.

What is being tested?

The study compares two methods of increasing keratinized tissue around teeth and implants: one using a patient's own gum tissue (Free Gingival Graft) and another combining this with an Acellular Dermal Matrix (Strip Gingival Graft + ADM).

What are the potential side effects?

Possible side effects may include discomfort at the graft site, swelling, bleeding, infection risk increase after surgery and potential for rejection of the ADM material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My gums do not have enough protective tissue around my teeth or implants.

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My teeth next to the treatment area are healthy, or I have healthy implants or gums.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had soft tissue grafting at the treatment site.

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I have active gum disease.

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I do not speak English.

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I am under 18 years old.

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I do not have any health conditions that would interfere with surgery or healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of soft tissue regenerated

Quantity of soft tissue regenerated (Width of Keratinized Tissue)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)Experimental Treatment1 Intervention

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 recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations. A strip of a free gingival graft is then harvested from the patient's palate. This strip is only 2 to 3 mm wide ,1 to 1.5 mm thick and has an appropriate length to cover the full apical extension of the recipient site. The strip is sutured immediately with 6-0 monocryl sutures. Coronal to the strip, the periosteal bed is covered with ADM, which is already rehydrated in sterile saline for 10 min, trimmed and customized to fit the available space. The ADM is then stabilized on the periosteal bed with the epithelium side facing upward. The ADM is fixed on the recipient bed by periosteal 6-0 monocryl sutures.

Group II: Free gingival graft.Active Control1 Intervention

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 will be 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Peri-implant Mucositis include soft tissue grafting techniques such as Free Gingival Graft (FGG) and Strip Gingival Graft with Acellular Dermal Matrix (SGG+ADM). FGG involves harvesting tissue from the patient's palate and grafting it to the affected area, which increases the amount of keratinized tissue and enhances the stability and health of the peri-implant mucosa. SGG+ADM combines a smaller autogenous tissue strip with an acellular dermal matrix, which serves as a scaffold to promote tissue integration and regeneration. These treatments are crucial for Peri-implant Mucositis patients as they improve the quality and quantity of the mucosal tissue around implants, reducing inflammation and the risk of further complications.