Soft Tissue Augmentation for Immediate Dental Implants

Overseen By I-Ching Wang, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Must not be taking: Bone metabolism drugs

Disqualifiers: Untreated periodontitis, Severe systemic disease, Radiotherapy history, Heavy smoking, Pregnancy, others

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

Compensation: Varies

Number of Visits: 17

Duration: 0 weeks (immediate)

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two types of grafts to help support the bone and gum tissue around a new tooth implant. It focuses on patients with thin gum and bone tissue, who are at higher risk for aesthetic problems. The study will compare the effectiveness of using the patient's own tissue versus a collagen matrix. Collagen matrices have been promoted as an alternative for augmenting soft tissue around dental implants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on long-term medications that affect bone metabolism, you may not be eligible to participate.

What data supports the effectiveness of the treatment Soft Tissue Augmentation for Immediate Dental Implants?

Research shows that soft tissue augmentation, including connective tissue grafting (CTG), can significantly enhance the thickness of soft tissue at dental implant sites, which is important for the stability and appearance of the implant. CTG has been found to be more effective than other methods like xenogenic collagen matrix (XCM) in improving soft tissue thickness before prosthetic treatment. ^{1 2 3 4 5}

Is soft tissue augmentation for dental implants safe for humans?

Soft tissue augmentation for dental implants, including techniques like connective tissue grafting (CTG) and using xenogenic collagen matrix (XCM), has been studied in humans and is generally considered safe. However, most studies have short-term follow-ups, so more research is needed to confirm long-term safety. ^{1 3 4 5 6}

How does the 'No Soft Tissue Augmentation' treatment for immediate dental implants differ from other treatments?

The 'No Soft Tissue Augmentation' treatment for immediate dental implants is unique because it does not involve additional procedures to increase soft tissue thickness, unlike other methods that use grafts or techniques to enhance tissue around the implant. This approach may be simpler and less invasive, focusing solely on the implant placement without altering the surrounding soft tissue. ^{4 7 8 9 10}

Research Team

Shaoping Zhang, DDS, MS, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for adults aged 18-95 with a single tooth needing replacement in the upper front area, who maintain good oral hygiene and have adequate bone support for an implant. Smokers, pregnant individuals, those with certain medical conditions or treatments affecting bone health or healing are excluded.

Inclusion Criteria

Postextraction vertical bone defect of the buccal socket wall was less than or equal to 3mm

Adequate oral hygiene (i.e., full-mouth bleeding score (FMBS) and full mouth plaque score (FMPS) of less than 25%)

I have enough space in my mouth for an immediate dental implant.

Exclusion Criteria

I have been on medication for bone health for over 3 months.

Heavy smoker (greater than 10 cigarettes per day)

I have had radiation therapy in my head or neck area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Immediate implant placement with or without soft tissue augmentation using CTG or VCMX

0 weeks (immediate)

1 visit (in-person)

Early Healing

Monitoring of dynamic changes in bone crest and soft tissue using ultrasonography

12 weeks

Multiple visits (in-person) at 0, 1, 2, 4, 6, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 weeks

Visits at 16, 24, and 48 weeks

Treatment Details

Interventions

• CTG
• No Soft Tissue Augmentation
• VCMX Graft

Trial Overview The study tests how well two different grafting techniques (CTG and VCMX) prevent gum and bone changes around new dental implants compared to no augmentation. It uses ultrasound imaging to monitor these changes over time.

Participant Groups

Group I: Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft Experimental Treatment 1 Intervention

Subjects in this arm will have Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft at the time of immediate implant placement.

Group II: Tuberosity Connective Tissue Graft (CTG) Experimental Treatment 1 Intervention

Subjects in this arm will have a tuberosity connective tissue graft at the time of immediate implant placement.

Group III: No Soft Tissue Augmentation Active Control 1 Intervention

Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement.

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Which type of soft tissue augmentation at dental implant sites is best supported by evidence? [2021]

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

Outcome measures and methods of assessment of soft tissue augmentation interventions in the context of dental implant therapy: A systematic review of clinical studies published in the last 10 years. [2023]

3. Denmark pubmed.ncbi.nlm.nih.gov

Esthetics and bone changes of immediate implants with or without vascularized interpositional periosteal connective tissue grafting: A 2-year randomized controlled trial. [2023]

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

Changes in Peri-implant Soft Tissue Thickness with Bone Grafting and Dermis Allograft: A Case Series of 15 Consecutive Patients. [2019]

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

Soft tissue management at implants: Summary and consensus statements of group 2. The 6th EAO Consensus Conference 2021. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Early soft tissue changes following implant placement with or without soft tissue augmentation using a xenogeneic cross-link collagen scaffold: A volumetric comparative study. [2022]

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

Pouch roll technique for implant soft tissue augmentation: a variation of the modified roll technique. [2013]

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

Ridge Augmentation Simultaneous With Immediate Implant Placement: The Subperiosteal Tunneling Technique. [2018]

9. India pubmed.ncbi.nlm.nih.gov

Soft-Tissue Augmentation in Periodontally Compromised Patients during Immediate Placement and Immediate Loading Dental Implant Surgery - A Retrospective Study. [2023]

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

Reconstructing Peri-implant and Papillary Soft Tissue in the Esthetic Area Using Interdental Tissue, a Tuberosity Connective Tissue Graft, and a Tunneling Approach: A Case Report. [2022]