Gum Graft Techniques for Gum Recession

Overseen By Carlos Garaicoa Pazmino, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Must not be taking: Antibiotics, Chemotherapy

Disqualifiers: Smoking, Uncontrolled diabetes, Infections, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 week

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the dimensional changes in the short and long-term in patients with thin gum tissues who have gum grafts placed on either denuded bone or gum grafts placed on a bone with some tissues remaining. The main question this study aims to answer is: - Does the placement of free-epithelized gingival grafts (gum grafts) on full thickness bed preparation (having all of the tissue removed from the bone) lead to similar clinical, digital, and patient-related outcomes and measurements over a period of 12 months versus split thickness bed preparation (where a small layer of tissue is left over the bone) in patients with thin gum tissue phenotypes (gum tissue is generally less than 1.5 millimeters) who are in need of soft tissue augmentation procedures? Participants will be asked to attend 8 visits, which include: (i) screening visit, (ii) prophylaxis visit, (iii) random assignment to Group A or Group B along with surgery and digital data collection, (iv) 2-week post-operative visit, (v) 6-week post-operative visit, (vi) 3-month follow-up visit, (vii) 6-month follow-up visit, (viii) 12-month follow-up visit. Also, Group A will have a free epithelialized gingival/mucosal graft (gum graft) placed on full thickness periosteal bed preparation where all of the tissue was removed (test group). Group B will have a free epithelialized gingival/mucosal graft (gum graft) on split thickness periosteal bed preparation where only a portion of the tissue was removed (control group). Researchers will compare Group A and Group B to see if there is a difference in clinical, digital, and patient-related outcomes and measurements over a period of 12 months.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that affect wound healing or have taken antibiotics in the past 3 months, you may not be eligible to participate.

What data supports the effectiveness of the treatment for gum recession?

Research shows that using techniques like the tunnel method with connective tissue grafts can effectively cover exposed roots and improve the appearance of gums. Studies comparing different methods, such as the tunnel technique and coronally advanced flap, have demonstrated positive outcomes in treating gum recession. ^{1 2 3 4 5}

Is gum grafting for gum recession safe?

Gum grafting techniques, including those using acellular dermal matrix grafts, have been shown to be generally safe with minimal postoperative pain and high patient satisfaction. These procedures are designed to improve gum health and appearance, and they typically have favorable outcomes with few complications. ^{4 6 7 8 9}

How does the Gum Graft Placed on Denuded Bone treatment differ from other treatments for gum recession?

The Gum Graft Placed on Denuded Bone treatment is unique because it involves placing a graft directly on the exposed bone, which may promote better integration and stability compared to other methods that focus on covering the root surface. This approach can potentially enhance the healing process and provide more predictable outcomes in terms of gum tissue regeneration. ^{1 2 7 10 11}

Research Team

Carlos Garaicoa, DDS, MS

Principal Investigator

University of Iowa College of Dentistry

Eligibility Criteria

This trial is for adults aged 18-95 with inactive gum disease, thin gums (<1.5mm depth), insufficient keratinized tissue, shallow vestibule depth, or aberrant frenum needing grafts. Eligible participants must not be current smokers and have no recent soft tissue procedures in the area of interest.

Inclusion Criteria

Thin gingival phenotype (less than 1.5mm of gum tissue depth)

My gum disease is not currently active.

Shallow vestibule depth

Exclusion Criteria

I do not have any ongoing infections.

I do not have any conditions or take medications that could affect my wound healing.

I have taken antibiotics in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Prophylaxis

Participants undergo prophylaxis before random assignment and surgery

1 week

1 visit (in-person)

Treatment

Participants are randomly assigned to Group A or Group B and receive gum graft surgery

1 week

1 visit (in-person)

Post-operative

Participants attend post-operative visits to monitor recovery and collect digital data

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person)

Treatment Details

Interventions

• Gum Graft Placed on Denuded Bone
• Gum Graft Placed on Split Thickness Periosteal Bed Preparation

Trial Overview The study compares two methods of placing gum grafts in patients with thin gums: directly on denuded bone versus on a split thickness bed with some tissue left. Over 12 months, researchers will assess clinical outcomes and patient satisfaction through eight scheduled visits.

Participant Groups

Group I: Gum Graft Placed on Denuded Bone Experimental Treatment 1 Intervention

Subjects in this arm will have a free epithelialized gingival/mucosal graft (gum graft) placed on full thickness periosteal bed preparation where all of the tissue was removed (test group).

Group II: Gum Graft Placed on Split Thickness Periosteal Bed Preparation Active Control 1 Intervention

Group B will have a free epithelialized gingival/mucosal graft (gum graft) on split thickness periosteal bed preparation where only a portion of the tissue was removed (control group).

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Findings from Research

In a study involving 14 patients with 20 cases of gingival recession, both acellular dermal matrix allograft (ADMA) and subepithelial connective tissue graft (SCTG) showed significant improvements in recession height, recession width, and keratinized gingiva after six months, indicating their effectiveness in treating gingival recession.

The results demonstrated that ADMA is a viable alternative to SCTG, as both techniques produced similar outcomes in root coverage and other clinical parameters, suggesting that ADMA can be used without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative clinical evaluation of acellular dermal matrix allograft and connective tissue graft for the treatment of gingival recession. Rahmani, ME., Lades, MA.[2022]

In a study of 18 patients with gingival recession, the tunnel technique combined with subepithelial connective tissue graft (TUN+CTG) showed significantly better clinical outcomes than the coronally advanced flap with enamel matrix derivative (CAF+EMD) after 5 years, with 50% of TUN+CTG sites achieving complete root coverage compared to 0% for CAF+EMD.

The TUN+CTG technique also resulted in greater recession reduction and thicker marginal soft tissue, indicating improved aesthetic outcomes, although there were no significant differences in patient-centered satisfaction between the two techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate for root coverage: 5-year results of an RCT using 3D digital measurement technology for volumetric comparison of soft tissue changes. Zuhr, O., Akakpo, D., Eickholz, P., et al.[2021]

References

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

A modification of the pedicle graft in the treatment of gingival recession. [2019]

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

Treatment of gingival recession with a modified "tunnel" technique and an acellular dermal connective tissue allograft. [2006]

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

Coronally advanced flap + connective tissue graft techniques for the treatment of deep gingival recession in the lower incisors. A controlled randomized clinical trial. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Comparative clinical evaluation of acellular dermal matrix allograft and connective tissue graft for the treatment of gingival recession. [2022]

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

Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate for root coverage: 5-year results of an RCT using 3D digital measurement technology for volumetric comparison of soft tissue changes. [2021]

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

Utilization of a Bovine Xenograft to Achieve Dental Root Coverage: A Pilot Study. [2020]

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

Free gingival grafts for the treatment of gingival recession. A review of some techniques. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Esthetic correction of gingival recession using a modified tunnel technique and an acellular dermal connective tissue allograft. [2013]

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

Evaluation of recession defects treated with coronally advanced flaps and either recombinant human platelet-derived growth factor-BB plus β-tricalcium phosphate or connective tissue: comparison of clinical parameters at 5 years. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Influence of immediate postoperative gingival thickness and gingival margin position on the outcomes of root coverage therapy: A 6 months prospective case series study using 3D digital measuring methods. [2023]

11. Egypt pubmed.ncbi.nlm.nih.gov

A Modified Bilaminar Technique with the Use of a Fibrin-Fibronectin System for a Single Gingival Recession: A Case Report with a Follow-Up of 3 Years. [2020]