Bone Augmentation Techniques for Peri-Implantitis

GL
Overseen ByGuo-Hao Lin, DDS, MS
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 aims to determine which of two bone grafting techniques better builds up bone next to dental implants. Researchers are comparing a method that mixes two graft materials (mixed bone augmentation) with one that layers them (sandwich bone augmentation). Individuals with at least 20 permanent teeth and one missing tooth spot in the upper jaw may qualify. As an unphased trial, this study offers a unique opportunity to contribute to dental research and potentially benefit from innovative treatment options.

What prior data suggests that these bone augmentation techniques are safe for dental implants?

Research has shown that mixed bone augmentation is generally well-tolerated. One study reported no negative effects, such as infections or significant bone loss, during the observation period, and the treatment succeeded in 94.2% of cases. Another study found that implants had a 99.0% survival rate after one year.

Unfortunately, specific safety data for sandwich bone augmentation is not available, making it difficult to provide solid safety evidence for this method. However, testing these common techniques in the trial suggests they are likely considered safe enough for further study.12345

Why are researchers excited about this trial?

Researchers are excited about these bone augmentation techniques for peri-implantitis because they offer new ways to tackle bone loss around dental implants. Unlike traditional treatments, which often involve surgical removal of infected tissue or mechanical cleaning, mixed bone augmentation combines bone graft materials to enhance bone regeneration. Meanwhile, the sandwich bone augmentation technique layers different types of graft materials, potentially providing a more stable and robust bone structure. These innovative approaches could lead to faster recovery times and more durable results, offering hope for patients struggling with peri-implantitis.

What evidence suggests that this trial's techniques could be effective for bone augmentation?

This trial will compare mixed bone augmentation with sandwich bone augmentation for treating peri-implantitis. Research has shown that both techniques work well for dental implants. Participants may receive mixed bone augmentation, which has successfully treated severe gum disease around implants, achieving a 97.9% success rate in maintaining implant stability. Alternatively, participants may receive sandwich bone augmentation, which demonstrated a 100% success rate in keeping implants stable over seven years, with noticeable bone growth six months post-procedure. These findings suggest that both methods effectively increase bone around dental implants, each showing strong results in different studies.678910

Who Is on the Research Team?

GL

Guo-Hao Lin, DDS, MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people who need more bone around their dental implants, often due to bone loss from conditions like peri-implantitis. Participants should be healthy enough for oral surgery and not have medical issues that would prevent healing.

Inclusion Criteria

I am missing one tooth in my upper front or side area.
I have enough space between my teeth for an implant crown.
The width of my jawbone where I have missing teeth is between 4 mm and 7 mm.
See 1 more

Exclusion Criteria

An implant without primary stability >35N
Current heavy smokers (>10 cigarettes per day) or heavy smokers who quitted less than 1 year
I have gum disease that is not under control.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dental implant placement with either mixed or sandwich bone augmentation techniques

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of bone gain and implant survival

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Mixed bone augmentation
  • Sandwich bone augmentation

Trial Overview

The study compares two ways of adding bone near dental implants: one mixes two graft materials together (mixed), while the other layers them on top of each other (sandwich). The goal is to see which method builds better bone.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Sandwich bone augmentationExperimental Treatment1 Intervention
Group II: Mixed bone augmentationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Geistlich Pharma AG

Industry Sponsor

Trials
45
Recruited
2,300+

Citations

Peri-Implantitis: A Clinical Update on Prevalence and Surgical ...

Results of a case series study indicated that a combined bone resection procedure with implantoplasty resulted in marginal bone level stability and disease ...

Treatment of advanced peri-implantitis with regenerative therapy

Of the 170 implants treated 48 had advanced peri-implantitis (>50% bone loss) with 47/48 (97.9%) of these implants having successful outcomes and were retained.

Surgical treatment of peri-implantitis | British Dental Journal

Studies have reported that sustained disease resolution could only be achieved in 53% of implants and 63% of patients following AFD, even when ...

Systematic Review Peri-Implant Therapy Efficacy of ...

Results of studies indicate that up to 80% of patients with implants may develop mucositis; approximately 20% eventually progress to peri-implantitis. ... These ...

Sandwich vs. Mixed Bone Augmentation for Implant ...

This study is being done to see which of two common grafting techniques-mixing two different grafting materials or layering two grafting materials-works ...

Effects of lateral bone augmentation procedures on peri

The incidence of peri- implantitis was evaluated in three investigations and varied from 16% to 26% after a follow- up period of 6–8 years.

Timing and Materials in Crestal Soft-Tissue Augmentation

No adverse effects or complications such as infection, excessive bone loss, or graft exposure were reported during the study period,

Bone Augmentation Procedures in Implant Dentistry

peri-implant bone resorp- tion rates higher than those proposed for successful implants, resulting in a success rate of 94.2% (Table 4).

Impact of peri‐implant soft tissue characteristics on health and ...

augmentation has been shown to render acceptable clinical outcomes compared to the free autogenous graft in areas free of disease and in sites ...

Clinical Study Protocol for Bone Augmentation with ...

Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%.