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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different treatments can help with gum and bone changes after an immediate dental implant, which replaces a tooth immediately after removal. The trial will compare three groups: one receiving a connective tissue graft (a piece of tissue from the mouth), another using a collagen matrix (a material from animal tissue), and one with no extra treatment ("No Soft Tissue Augmentation"). The goal is to determine which approach helps the gums and bone heal better and look more natural over time. Suitable participants have a single tooth needing replacement in the front upper teeth area and maintain good oral hygiene. As an unphased trial, this study offers a unique opportunity to contribute to dental research and potentially improve future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies using a tuberosity connective tissue graft (CTG) with immediate dental implants have shown successful results for appearance. This method stabilizes the soft tissue around the implant, which is crucial for both aesthetics and function. Although there is a small risk of uneven soft tissue levels, this occurrence is uncommon.

Research on the xenogeneic volume-stable collagen matrix (VCMX) indicates it can thicken the soft tissue around implants, enhancing appearance. However, it may not increase tissue thickness as effectively as CTG. Both treatments have been tested in people and are generally well-tolerated, with most individuals not experiencing serious side effects. These findings provide evidence of safety for both CTG and VCMX in dental implant procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the trial for soft tissue augmentation in dental implants because it explores innovative ways to improve healing and aesthetics after immediate implant placement. The Tuberosity Connective Tissue Graft (CTG) uses tissue from the patient's own mouth, potentially enhancing integration and reducing rejection risk. Meanwhile, the Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft offers a synthetic alternative that maintains volume stability, which might simplify the procedure and reduce patient discomfort compared to traditional grafts. By comparing these methods to no augmentation, researchers aim to discover optimal strategies for tissue management, potentially revolutionizing post-implant recovery and outcomes.

What evidence suggests that this trial's treatments could be effective for mid-facial recession following immediate dental implants?

This trial will compare different approaches to soft tissue augmentation for immediate dental implants. Research has shown that using connective tissue grafts (CTG), one of the treatments in this trial, can lead to better aesthetic outcomes with dental implants. Studies have found that placing CTG with an implant immediately helps maintain tissue stability around the implant. A study that followed patients for five years supports this, showing that CTG can improve results when replacing a damaged tooth with an implant.

For the xenogeneic volume-stable collagen matrix (VCMX), another treatment option in this trial, research suggests it doesn't increase soft tissue thickness as much as CTG. However, VCMX is considered a good alternative for enhancing soft tissue. Some studies have found that while it might not thicken the tissue as much, it provides similar short-term aesthetic results without needing tissue from the patient's own body. ^{1 6 7 8 9}

Who Is on the Research Team?

Shaoping Zhang, DDS, MS, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11202705/

Association of Connective Tissue Grafts in Immediate Implants CTG is favorable for achieving successful esthetic results when immediate placement of an implant with a provisional prosthesis is planned.

2. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/full/10.1002/JPER.24-0660

Efficacy of soft tissue augmentation in the maxillary esthetic ... Soft tissue grafting at single implant placement after alveolar ridge preservation, either with a CTG or XCM, does not result in a better esthetic outcome.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10856075/

The Use of Tissue Grafts Associated with Immediate Implant ... The use of tissue grafts associated with immediate implant placement to achieve better peri-implant stability and efficacy: a systematic review and meta- ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jcpe.13918

Single immediate implant placement in the maxillary ... This 5-year follow-up study shows that grafting connective tissue when replacing a single failing tooth with immediately placed and provisionalized implant ...

5. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-025-05461-0

Hard and soft tissue alterations after the application of different ... The aim of this review is to compare the clinical outcomes of different soft tissue grafting materials (connective tissue graft (CTG), platelet-rich fibrin (L- ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1991790224000680

Soft tissue management around dental implant in esthetic ... A randomized clinical trial has shown similar short-term outcomes when compared ADM to CTG in terms of peri-implant mucosal thickness, width of keratinized ...

7. atelierdentalmadrid.com atelierdentalmadrid.com/assets/descargas/papers/16.%20Rojo%20et%20al%20(2020)%20Soft%20tissue%20stability%20around%20dental%20implants%20after%20soft%20tissue%20grafting%20from%20the%20lateral%20palate%20or%20the%20tuberosity%20area%20%E2%80%93%20A%20randomized%20controlled%20clinical%20study.pdf

Soft tissue stability around dental implants after ... Aim: To compare the soft tissue stability (STA) around single implants previously aug- mented with either subepithelial connective tissue graft ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0261513

Does simultaneous soft tissue augmentation around ... The current meta-analysis aimed to compare the effect of simultaneous soft tissue augmentation using subepithelial connective tissue graft (SCTG) around ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/jcpe.13397

Immediate implant placement with or without connective ... This outcome was clinically relevant since the risk for ≥1 mm asymmetry in mid-facial vertical soft tissue level was 12 times (RR 12.10, 95% CI ...