Grafting Materials for Misaligned Teeth

Overseen By Nikola Angelov

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Smoking, Pregnancy, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 data supports the effectiveness of the treatment Allograft with Collagen Membrane, Xenograft with Collagen Membrane for misaligned teeth?

Research shows that using xenografts (materials from another species) with collagen membranes can help improve bone and gum conditions in dental procedures, such as enhancing periodontal health after tooth extractions and increasing gum tissue around implants. This suggests that similar materials might be effective in treating misaligned teeth by supporting bone and gum health. ^{1 2 3 4 5}

Is the use of grafting materials for misaligned teeth safe?

Some studies have shown that bovine-derived graft materials, often used in dental procedures, can lead to complications like inflammation, implant failure, and other issues. These materials are not biodegradable, and removing them can be complex, raising concerns about their long-term safety. ^{2 4 6 7 8}

How does the treatment using Allograft with Collagen Membrane and Xenograft with Collagen Membrane for misaligned teeth differ from other treatments?

This treatment is unique because it uses grafting materials like allografts (from human donors) and xenografts (from animals) combined with collagen membranes to potentially improve bone and soft tissue support around teeth. This approach is different from traditional methods as it focuses on enhancing periodontal (gum and bone) health, which may not be the primary focus of other treatments for misaligned teeth. ^{2 3 4 9 10}

What is the purpose of this trial?

The purpose of this study is to quantitatively investigate the radiographic changes of alveolar bone, and gingival tissue changes of the mandibular anterior teeth in experimental group A receiving SFOT using freeze-dried allograft with a collagen membrane, experimental group B receiving SFOT using particulate xenograft covered by a collagen membrane and control group receiving only orthodontics therapy.

Research Team

Sahar Dowlatshahi, DDS, MMSc

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for individuals with misaligned teeth or malocclusion. Participants should be suitable candidates for orthodontic therapy and willing to undergo surgical procedures as part of their treatment.

Inclusion Criteria

Incisor mandibular plane angle between 90-100 degrees

Class I malocclusion

Crowding of 4 mm or less on mandibular anterior incisors

Exclusion Criteria

Patients who are current smokers

Pregnancy

My lower front teeth lean too far backward.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive surgically facilitated orthodontics therapy with different grafting materials

4 months

Regular visits for orthodontic adjustments

Follow-up

Participants are monitored for radiographic changes and gingival tissue changes

4 weeks

Treatment Details

Interventions

• Allograft with Collagen Membrane
• Xenograft with Collagen Membrane

Trial Overview The study tests the effects of surgically facilitated orthodontics therapy (SFOT) using two different graft materials: freeze-dried allograft and particulate xenograft, each paired with a collagen membrane, compared to usual care without SFOT.

Participant Groups

Group I: Group B Experimental Treatment 1 Intervention

Group II: Group A Experimental Treatment 1 Intervention

Group III: Control group Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

American Academy of Periodontology Foundation

Collaborator

Trials

1

Recruited

20+

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of xenogeneic collagen matrix versus free gingival grafts for keratinized mucosa augmentation around dental implants: A randomized controlled clinical trial. [2021]

2. Denmark pubmed.ncbi.nlm.nih.gov

Buccal bone deficiency in fresh extraction sockets: a prospective single cohort study. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

The effect of ostrich acellular dermal matrix on keratinized gingival width. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Does grafting of third molar extraction sockets enhance periodontal measures in 30- to 35-year-old patients? [2012]

5. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy of keratinized mucosal augmentation with a collagen matrix concomitant to the surgical treatment of peri-implantitis: A dual-center randomized clinical trial. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Retraction. [2019]

7. India pubmed.ncbi.nlm.nih.gov

The long-term risks and complications of bovine-derived xenografts: A case series. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Bone remodelling marker expression in grafted and ungrafted sheep tooth extraction sockets: A comparative randomised study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Gingival Thickening Following the Use of Allogeneic Acellular and Xenogeneic Collagen Matrix: A 12-Month Randomized Clinical Trial. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Biocompatibility Evaluation of Human and Porcine Acellular Dermal Matrix on Human Primary Gingival Fibroblasts: In Vitro Comparative Study. [2021]