What side effects are associated with this type of intervention?

Connective Tissue Graft (CTG) Augmentation for Immediate Implant Placement (IIP) can lead to donor site morbidity, including pain, bleeding, infection, and prolonged healing times. Xenogeneic Volume-Stable Collagen Matrix (VCMX) aims to avoid these donor site issues but may still pose risks such as infection, inflammation, and potential allergic reactions. Both treatments support tissue regeneration and esthetic outcomes but come with their respective side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for soft tissue augmentation and regeneration, which are relevant to Immediate Implant Placement (IIP). Connective Tissue Graft (CTG) Augmentation is a well-established procedure that provides additional connective tissue to support gum and bone structure, commonly used in dental surgeries. Xenogeneic Volume-Stable Collagen Matrix (VCMX) is another treatment option that supports tissue regeneration and avoids morbidity, although specific FDA approvals for VCMX in the context of IIP are not detailed. Both treatments aim to enhance the stability and aesthetic outcomes of dental implants by mitigating tissue recession and promoting healing.

What other types of research exist?

Promising novel alternatives to CTG and VCMX for Immediate Implant Placement patients include the use of autologous fat transfer and recombinant protein therapy. Autologous fat transfer offers soft tissue augmentation without the risk of allergic reactions and has shown potential in various contour defect corrections. Recombinant protein therapy, particularly with human recombinant collagen type VII, has demonstrated the ability to restore tissue integrity and support healing in preclinical studies. Both methods represent innovative approaches that could enhance tissue regeneration and clinical outcomes in dental implant procedures.

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Soft Tissue Augmentation for Immediate Dental Implants

N/A

Waitlist Available

Led By Shaoping Zhang, DDS, MS, PhD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate tooth space to support an immediate implant placement (i.e., adequate mesiodistal space of greater than or equal to 6 mm and interocclusal space to support a non-occluding provisionalization).

Must not have

Patients taking long-term (more than 3 months) medications affecting bone metabolism

History of radiotherapy in the head and neck region

Timeline

Screening 3 weeks

Treatment Varies

Follow Up multiple time points (i.e. 0, immediately after implant placement, 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks after immediate implant placement)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the graft site, swelling, bruising, bleeding or infection. The CTG procedure might also cause additional pain where tissue was taken from.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am between 18 and 95 years old.

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I have one bad tooth in the front upper part of my mouth.

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My tooth socket's outer wall bone loss is 3mm or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have severe gum disease with deep pockets and bleeding gums.

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My gum has receded on the tooth opposite the one to be extracted.

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I have a severe health condition that makes surgery risky.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ multiple time points (i.e. 0, immediately after implant placement, 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks after immediate implant placement)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~multiple time points (i.e. 0, immediately after implant placement, 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks after immediate implant placement)

This trial's timeline: 3 weeks for screening, Varies for treatment, and multiple time points (i.e. 0, immediately after implant placement, 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks after immediate implant placement) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in from Baseline in Soft and Hard Tissue Thickness as assessed by ultrasound

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Xenogeneic Volume-Stable Collagen Matrix (VCMX) graftExperimental Treatment1 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 Treatment1 Intervention

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

Group III: No Soft Tissue AugmentationActive Control1 Intervention

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immediate Implant Placement (IIP) often faces challenges such as mid-facial recession and soft tissue remodeling. Two common treatments to address these issues are Connective Tissue Graft (CTG) Augmentation and Xenogeneic Volume-Stable Collagen Matrix (VCMX). CTG provides additional connective tissue, which supports the gum and bone structure, reducing the risk of soft tissue recession and enhancing the stability of the peri-implant tissue. VCMX, on the other hand, supports tissue regeneration and avoids the morbidity associated with harvesting autogenous tissue. Both treatments aim to improve the esthetic and functional outcomes of IIP by stabilizing the gingival margin and promoting healthy tissue integration.

Sectional Connective Tissue Technique Combined With an Emergence Profile Provisional for Gingival Margin Stabilization During Immediate Implant Placement: A Case Report With a 2-Year Follow-Up.Effect of connective tissue grafting on peri-implant tissue in single immediate implant sites: A RCT.