Acellular Dermis for Dental Implants

MG
SS
Overseen BySarah Startley, DMD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of acellular dermis, a tissue-like material, in aiding dental implants. It compares the use of this material during two stages of implant surgery to determine if it enhances the soft tissue around the implant. Suitable candidates have a gap in their teeth and plan to receive a dental implant but lack sufficient soft tissue in the area. Participants must be patients at the UAB Dental School and have healthy neighboring teeth. As an unphased trial, this study provides a unique opportunity to contribute to innovative dental research and potentially improve future implant procedures.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that acellular dermis is safe for dental implant procedures?

Research has shown that using acellular dermis in dental implant procedures is generally safe. Studies have found that it increases the thickness of gum tissue around implants, leading to stable and healthy results. For instance, one study reported a 100% success rate for implants, with only minor issues. Another study observed that the gum tissue remained healthy and stable for about 22 months, and all implants were successful.

Overall, using acellular dermis in dental procedures has been well-received, with positive outcomes for gum health and implant stability. This suggests that acellular dermis is a safe choice for improving soft tissue during dental implant surgery.12345

Why are researchers excited about this trial?

Researchers are excited about using acellular dermis for dental implants because it offers a novel approach for enhancing soft tissue around implants. Unlike traditional methods that may involve grafting tissue from another part of the patient's mouth, acellular dermis provides a ready-made scaffold without the need for additional surgery. This technique could simplify the process, reduce patient discomfort, and potentially improve healing times. The ability to encourage natural tissue integration with fewer complications makes this approach stand out from current options.

What evidence suggests that acellular dermis is effective for dental implants?

Research has shown that acellular dermis can enhance the health of gums and other oral tissues surrounding dental implants. In this trial, participants will undergo different phases involving acellular dermis. Studies have found that using acellular dermis results in a 100% success rate for implant placement, with only minor issues. It thickens the tissue around implants, although it has little effect on bone loss or gum pocket depth. Overall, results for tissue volume and stability have been positive. In summary, acellular dermis improves the health and stability of tissue around dental implants.14678

Who Is on the Research Team?

ML

Maria L Geisinger, DDS, MS

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults (18+) who are patients at the UAB Dental School and need a dental implant in an area with thin or insufficient gum tissue. Participants must have healthy neighboring teeth or implants, not need other dental surgeries nearby during the study, and be able to read English.

Inclusion Criteria

I have one missing tooth area needing an implant with not enough healthy gum tissue.
I have healthy teeth or implants next to the area where I need a dental implant.
I do not expect to need dental or root canal work near the surgery site during the study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Dental implant placement followed by soft tissue augmentation using acellular dermis

6 months

Phase II Treatment

Dental implant uncovery and soft tissue augmentation using acellular dermis

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acellular Dermis

Trial Overview

The study compares two ways of using acellular dermal matrix (a type of soft tissue graft) around dental implants: either during initial implant placement (Phase I) or when uncovering the implant later (Phase II).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Phase II dental implant uncovery with acellular dermisExperimental Treatment1 Intervention
Group II: Phase I dental implant placement with acellular dermisActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Immediate Implant Placement with Soft Tissue Augmentation ...

The overall success rate of the implants in this review was reported to be 100%, with minor complications noted in one of the studies [27]. The ...

Efficacy of Acellular Dermal Matrix in Soft Tissue ...

This study was done to perform a systematic review and meta-analysis of the studies on the efficacy of acellular dermal matrix (ADM) in increasing the soft ...

Effectiveness of a porcine-derived acellular dermal matrix...

This prospective study assessed the clinical effectiveness of PADM for peri-implant soft-tissue augmentation in the anterior maxillary region ...

Review Efficacy of Acellular dermal matrix simultaneous ...

While Acellular dermal matrix significantly improves vertical soft tissue thickness, it does not significantly impact marginal bone loss or pocket probing depth ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35881814/

Efficacy of Acellular Dermal Matrix in Soft Tissue ...

This study was done to perform a systematic review and meta-analysis of the studies on the efficacy of acellular dermal matrix (ADM) in increasing the soft ...

Effect of Soft Tissue Augmentation With an Acellular ...

The main objective of this study is to evaluate the efficacy of an acellular dermal matrix membrane to increase the peri-implant soft tissue thickness and ...

Soft-Tissue Volume Augmentation at Dental Implant ... - PMC

At the last follow-up (mean 22.1 ± 15.0 months), the peri-implant soft tissue was healthy and stable, and all implants were surviving and ...

Soft Tissue Graft Placement Using a Porcine Acellular ...

The clinical outcomes were evaluated over a period of 3–6 months using STL imaging and direct measurements. Results: All patients showed an improvement in their ...