Dental Implant Techniques for Tooth Loss

Overseen By Robert Kelley, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Pregnancy, Smoking, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Day of surgery

28 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two methods for placing dental implants with added bone. It targets patients who need both a dental implant and extra bone support. The study compares different methods to see which one results in better healing after a few months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Submerged Technique, Transmucosal Technique for tooth loss?

Research shows that both submerged and transmucosal techniques for dental implants have similar success rates and patient satisfaction, with minimal bone loss. Studies indicate that both methods are effective for restoring missing teeth, providing reliable outcomes over time. ^{1 2 3 4 5}

Is the dental implant technique safe for humans?

Research shows that both submerged and transmucosal dental implant techniques have satisfactory success rates and similar safety outcomes, with minimal bone loss reported. Studies indicate good short-term and long-term results, suggesting these techniques are generally safe for humans. ^{1 2 3 6 7}

How do the submerged and transmucosal techniques for dental implants differ from other treatments for tooth loss?

The submerged and transmucosal techniques for dental implants are unique because they offer different healing approaches: the submerged technique involves placing the implant under the gum for healing, while the transmucosal technique allows the implant to heal through the gum. Both methods have shown similar success rates, but the transmucosal approach can avoid a second surgery, reduce treatment costs, and simplify the process. ^{1 2 3 4 5}

Research Team

Stavros Sofos, DDS

Principal Investigator

Nova Southeastern University

Eligibility Criteria

This trial is for adults over 21 who need a single tooth replaced and bone shaping, have no active gum disease, can come back for check-ups over 4 months, had a tooth taken out at least 8 weeks ago, and are generally healthy. Smokers of more than 10 cigarettes a day or pregnant individuals cannot join.

Inclusion Criteria

Availability for 4-month follow-up.

Available pre-operative CBCT study.

I need a single tooth replaced and the area around it reshaped.

Exclusion Criteria

Pregnancy at the screening visit.

Vertical bone defect less than 2mm (intra surgical assessment).

I have several missing teeth next to each other.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dental implant placement with contour augmentation, randomized into submerged and non-submerged healing groups

Day of surgery

Healing Evaluation

Healing is evaluated at 4 months post-operation compared to the day of surgery

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Submerged Technique
• Transmucosal Technique

Trial Overview The study compares two ways to put in dental implants with bone augmentation: the Transmucosal Technique (non-submerged) versus the Submerged Technique. It's random which method patients get.

Participant Groups

Group I: Transmucosal (Non-Submerged) Experimental Treatment 1 Intervention

Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure

Group II: Submerged Active Control 1 Intervention

Flaps will be advanced to achieve primary wound closure.

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Implant-supported single tooth restoration in the aesthetic zone: transmucosal and submerged healing provide similar outcome when simultaneous bone augmentation is needed. [2013]

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

Submerged and transmucosal healing yield the same clinical outcomes with two-piece implants in the anterior maxilla and mandible: interim 1-year results of a randomized, controlled clinical trial. [2022]

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

Apical-coronal implant position: recent surgical proposals. Technical note. [2007]

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

Clinical experience with one-stage, non-submerged dental implants. [2022]

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

Modeling of Crestal Bone After Submerged vs Transmucosal Implant Placement: A Systematic Review with Meta-Analysis. [2019]

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

Five-year outcomes of a randomized clinical trial comparing bone-level implants with either submerged or transmucosal healing. [2018]

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

Early and late implant failure of submerged versus non-submerged implant healing: A systematic review, meta-analysis and trial sequential analysis. [2022]