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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for placing gum grafts to treat gum recession in individuals with thin gum tissue. Researchers aim to determine if removing all tissue from the bone before placing the graft (Gum Graft Placed on Denuded Bone) is as effective as leaving a thin tissue layer (Gum Graft Placed on Split Thickness Periosteal Bed Preparation). They will compare the effectiveness of each method over 12 months, focusing on healing and patient comfort. Individuals with thin gums, gum recession in the front bottom teeth, and who do not smoke may be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to enhance understanding of effective treatments for gum recession.

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 prior data suggests that these gum graft techniques are safe?

Research has shown that gum grafts, like those under study, usually yield good results but can cause discomfort. Patients often report pain, swelling, and bruising, particularly if the surgery exceeds an hour. Healing typically takes about 4-8 weeks. Some studies have identified risks such as bone loss and further gum recession over time. However, gum grafts generally prove effective for treating gum recession. Prospective participants should discuss any concerns or questions with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the gum graft techniques being tested because they explore innovative ways to treat gum recession. Unlike traditional methods, which often use a gum graft on a split thickness periosteal bed, one approach in this trial uses a graft on denuded bone, where all the tissue is removed. This technique could potentially enhance healing and integration of the graft by providing a more stable and direct contact with the bone. If successful, it might offer a more effective solution for patients suffering from gum recession, leading to better long-term outcomes.

What evidence suggests that these gum graft techniques are effective for gum recession?

This trial will compare two gum graft techniques for treating receding gums. Research has shown that gum grafts placed directly on exposed bone, which participants in one arm of this trial will receive, have a success rate of over 90%, making them a reliable choice for covering exposed roots. However, the graft might shrink or the tissue might not survive if it doesn't receive enough blood. Participants in another arm of this trial will receive the split thickness approach, which leaves some tissue on the bone and has success rates between 84.83% and 87.7% for treating receding gums. Both methods help increase the width of the tough gum tissue, which is important for healthy gums. ^{6 7 8 9 10}

Who Is on the Research Team?

Carlos Garaicoa, DDS, MS

Principal Investigator

University of Iowa College of Dentistry

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11022508/

Treatment of Gingival Recession and Root Coverage ... The success rates ranged from 11% to 53% for gingival grafts [10]. The success rate of the subepithelial connective tissue graft technique ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3722996/

Surgical management of gingival recession: A clinical update Encouraging results could be also achieved when bone grafts were added ... graft: results of 107 recession defects in 50 consecutively treated patients.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0020653920365199

Treatment of Gingival Recession: When and How? The portion of a FGG placed on the denuded root surface does not have a good blood supply, and therefore, graft shrinkage or early necrosis may occur.

4. anthemperio.com anthemperio.com/what-is-the-success-rate-for-a-free-gingival-graft/

What is the Success Rate for a Free Gingival Graft? Gingival grafts are historically a highly successful procedure with a success rate higher than 90%. Gum grafts are effective in treating gum recession.

5. journals.lww.com journals.lww.com/jisp/fulltext/2019/23020/efficacy_of_free_gingival_graft_in_the_treatment.4.aspx

Efficacy of free gingival graft in the treatment of Miller... The result of this systematic review presented with greater reduction in gingival recession depth with gain in WKG and CAL and reduction in probing depth ...

6. arlingtondentalma.com arlingtondentalma.com/blog/gum-graft-surgery-success-and-possible-complications

Gum Graft Surgery: Success and Possible Complications Soft tissue healing generally takes 4-8 weeks to return to normal. Healing time also depends on how much tissue (thickness and area) was taken ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29873085/

Long-term evaluation (20 years) of the outcomes ... Thus, the aims of this study are two-fold: 1) to evaluate the long-term outcomes following SCTG + CAF in the treatment of gingival recessions (GR) and 2) to ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772559624000671

Soft tissue conditioning around teeth: A narrative review Despite the latter being less aggressive, both techniques resulted in bone loss, gingival recession, and inconsistent gains of KT [26,[81], [82], [83], [84], [ ...

9. brookhavendentalassociates.com brookhavendentalassociates.com/post/when-is-it-too-late-for-gum-grafting

When Is It Too Late For Gum Grafting? Advanced recession can lead to tooth mobility, infection, and bone loss. Attempting gum grafting too late may increase the risks of graft ...

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/prd.12468

Complications and treatment errors in root coverage ... Patients reported experiencing more pain, swelling, and bruising when the duration of the periodontal surgery was 60 minutes or longer. Pain ...