Root Coverage Procedures for Gum Recession

Overseen By Clara Sous

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Steroids

Disqualifiers: Smoking, Diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two procedures to treat gum recession in the lower front teeth. The aim is to determine which method better covers exposed tooth roots and increases gum tissue. One method uses a Coronally Advanced Flap (CAF) with a Connective Tissue Graft (CTG), while the other employs a Gingival Pedicle Split Thickness flap (GPST) with CTG. These procedures are collectively known as the Mandibular Incisor root coverage procedure. Individuals with gum recession of 3 mm or more in the front lower teeth who are otherwise healthy may be suitable candidates for this study. As an unphased trial, this study provides an opportunity to explore innovative 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, but you cannot participate if you are taking medications known to interfere with periodontal tissue health or healing.

What prior data suggests that these root coverage procedures are safe for treating gum recession?

Research has shown that combining the Gingival Pedicle Split Thickness flap (GPST) with a Connective Tissue Graft (CTG) effectively improves gum recession. Studies have found this method enhances the gums around the lower front teeth.

Similarly, the Coronally Advanced Flap (CAF) with CTG is a trusted method for covering exposed tooth roots. It has proven more effective than using CAF alone, even over a long period.

Both techniques, GPST + CTG and CAF + CTG, have been tested in various studies and show positive results in treating gum recession. Research indicates no major safety concerns, and these procedures are generally well-tolerated, usually not causing serious side effects. For those considering a trial with these treatments, evidence suggests they are safe options for addressing gum recession. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for gum recession because they explore innovative surgical techniques for root coverage. The GPST + CTG procedure combines a Gingival Pedicle Split Thickness with a Connective Tissue Graft, which is a novel approach aiming to enhance the gum's ability to cover exposed roots more effectively. Meanwhile, the CAF + CTG method uses a Coronally Advanced Flap with a Connective Tissue Graft, a technique that might offer improved stability and aesthetics compared to traditional methods. Both approaches have the potential to lead to better outcomes in terms of healing and cosmetic results, providing new hope for patients with gum recession.

What evidence suggests that this trial's treatments could be effective for gum recession?

This trial will compare two root coverage procedures for gum recession. Research has shown that the Coronally Advanced Flap (CAF) with a Connective Tissue Graft (CTG), one of the procedures in this trial, effectively treats gum recession. Studies have found that this combination covers exposed tooth roots better than other methods and is often considered the best option. Meanwhile, the Gingival Pedicle Split Thickness (GPST) procedure with CTG, another procedure being tested, has shown reliable improvement in gum recession, especially for the front lower teeth. Both treatments aim to cover exposed roots and increase gum tissue. Overall, both methods show promising results, but CAF + CTG has demonstrated more proven long-term success. ^{1 3 6 7 8}

Who Is on the Research Team?

Gian Pietro Schincaglia, DDS, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with specific types of gum recession on their lower front teeth, who haven't had prior surgery there. They must be generally healthy, not have diabetes that's out of control, aren't pregnant or breastfeeding, and don't use tobacco heavily or have diseases affecting connective tissue.

Inclusion Criteria

Presence of identifiable cemento-enamel junction (CEJ)

You have a small step or abrasion on the tooth, but the root and its base are still intact.

I can have gum surgery and am not on medications that affect gum health.

Exclusion Criteria

You regularly use e-cigarettes, chew tobacco, or smoke more than 10 cigarettes a day.

My gum recession is due to cavities.

My diabetes is not well-controlled (HbA1c > 7).

Timeline for a Trial Participant

Screening and Recruiting

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Therapy and Baseline Clinical Measurements

Participants receive prophylaxis and instructions in proper oral hygiene measures; baseline clinical measurements are taken

1 week

1 visit (in-person)

Surgical Therapy

Participants undergo either CAF+CTG or GPST+CTG surgical procedures for root coverage

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for post-operative recovery, including suture removal and outcome measurements

6 weeks

2 visits (in-person)

Clinical Measurements

Clinical measurements are taken to assess the outcomes of the surgical procedures

6 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mandibular Incisor root coverage procedure

Trial Overview The study compares two surgical methods to cover a receded gum area around the lower front tooth: one uses Coronally Advanced Flap with Connective Tissue Graft (control), and the other uses Gingival Pedicle Split Thickness flap with CTG (test).

How Is the Trial Designed?

Group I: GPST + CTG Experimental Treatment 1 Intervention

Gingival Pedicle Split Thickness + Connective Tissue Graft procedure

Group II: CAF + CTG Active Control 1 Intervention

Coronally Advanced Flap + Connective Tissue Graft procedure

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Published Research Related to This Trial

In a 10-year follow-up study of 21 patients with maxillary gingival recession, the combination of connective tissue graft (CTG) and coronally advanced flap (CAF) resulted in 63% of patients maintaining complete root coverage, compared to only 20% in the CAF alone group, indicating a significant long-term benefit of the combined approach.

The addition of CTG not only improved the likelihood of maintaining root coverage but also led to greater gains in keratinized tissue, suggesting that this technique enhances both aesthetic and functional outcomes in periodontal treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term comparison of root coverage procedures at single RT2 maxillary gingival recessions: Ten-year extension results from a randomized, controlled clinical trial. Cairo, F., Cortellini, P., Barbato, L., et al.[2023]

In a study involving 60 patients with gingival recession, both the coronally advanced flap combined with a sub-epithelial connective tissue graft (CAF+SCTG) and with leukocyte- and platelet-rich fibrin (CAF+L-PRF) significantly increased gingival thickness compared to the CAF alone, indicating their effectiveness in enhancing gingival phenotype.

The CAF+SCTG technique not only provided a greater increase in keratinized tissue width but also showed a more predictable outcome for gingival thickness, although it was associated with more discomfort and pain compared to the other techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gingival phenotype changes after different periodontal plastic surgical techniques: a single-masked randomized controlled clinical trial. Santamaria, P., Paolantonio, M., Romano, L., et al.[2023]

A novel surgical technique combining a modified tunnel approach with a subepithelial connective tissue graft and frenuloplasty was successfully used to treat deep labial recessions on mandibular incisors, achieving complete root coverage.

The results were maintained for 5 years, demonstrating the long-term efficacy and aesthetic success of this combined approach in a 20-year-old female patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Surgical Approach for Mandibular Anterior Root Coverage by Modified Tunnel Technique With Simultaneous Frenuloplasty: Technical Description and 5-Year Recall Case Report. Rimbert, M., Barré, R.[2021]

In a study involving 50 patients, both connective tissue grafts (CTG) and de-epithelialized gingival grafts (DGG) used in coronally advanced flap procedures showed no significant differences in post-operative pain, discomfort, or bleeding.

However, the CTG group reported lower stress and better chewing ability, while the DGG group had a greater increase in buccal soft tissue thickness, indicating that both graft types have their own benefits in terms of patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. Zucchelli, G., Mele, M., Stefanini, M., et al.[2022]

In a study of 50 patients with multiple gingival recessions, the combination of coronally advanced flap (CAF) and connective tissue graft (CTG) showed significantly better long-term root coverage and aesthetic outcomes at 5 years compared to CAF alone.

While both treatments had similar short-term results, the CAF + CTG group demonstrated greater recession reduction and improved contour evaluations by an independent periodontist after 5 years, although CAF alone had a better post-operative course and color match.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronally advanced flap with and without connective tissue graft for the treatment of multiple gingival recessions: a comparative short- and long-term controlled randomized clinical trial. Zucchelli, G., Mounssif, I., Mazzotti, C., et al.[2014]

The partial-thickness double pedicle flap and connective tissue graft procedure effectively achieved a mean root coverage of 75% over a follow-up period of 8 to 15 years, indicating its long-term efficacy in treating gingival recession.

Despite the procedure's effectiveness, the aesthetic outcomes were rated as mediocre, suggesting that alternative techniques may be more suitable for patients with higher aesthetic demands, as patients reported higher satisfaction compared to clinicians' assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up on Root Coverage with a Double Pedicle Flap and Connective Tissue Graft. Wessels, R., Eghbali, A., De Roose, S., et al.[2020]

The bilaminar root coverage technique using an autogenous subepithelial connective tissue graft (SCTG) combined with a coronally advanced flap (CAF) was found to be the most effective treatment for single gingival recession defects, based on a systematic review of 38 studies involving 830 patients.

This technique not only achieved the highest rates of complete root coverage and mean root coverage but also improved keratinized tissue width significantly at both 6 and 12 months post-surgery, establishing it as the gold standard for this type of dental procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the subepithelial connective tissue graft in conjunction with a coronally advanced flap remain as the gold standard therapy for the treatment of single gingival recession defects? A systematic review and network meta-analysis. Chambrone, L., Botelho, J., Machado, V., et al.[2022]

The modified microsurgical tunnel technique (MMTT) combined with connective tissue graft (CTG) resulted in significantly better clinical and patient-related outcomes compared to the modified coronally advanced flap (MCAF) with CTG for treating multiple adjacent gingival recessions.

MMTT preserves blood supply and promotes faster healing while maintaining esthetics, leading to lower morbidity and higher patient satisfaction, making it a superior option for gingival recession treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Multiple Adjacent Class I and Class II Gingival Recessions by Modified Microsurgical Tunnel Technique and Modified Coronally Advanced Flap Using Connective Tissue Graft: A Randomized Mono-center Clinical Trial. Karmakar, S., Kamath, DSG., Shetty, NJ., et al.[2022]

In a study involving 18 patients with gingival recessions, both the porcine collagen matrix (PCM) plus coronally advanced flap (CAF) and the traditional connective tissue graft (CTG) plus CAF showed significant reductions in gingival recession after 12 months, indicating both methods are effective.

There were no significant differences in clinical outcomes such as root coverage percentage, clinical attachment level gain, or keratinized tissue width between the PCM+CAF and CTG+CAF groups, suggesting that PCM could be a viable alternative to CTG for treating gingival recessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. Cardaropoli, D., Tamagnone, L., Roffredo, A., et al.[2013]

The tunneled coronally advanced flap (TCAF) combined with a connective tissue graft (CTG) showed a high average root coverage of 86.5% after 6 months in 10 patients with isolated type 2 gingival recessions, indicating its efficacy in treating this condition.

Patients experienced minimal discomfort during recovery, and the technique resulted in significant improvements in gingival thickness and keratinized tissue width, suggesting enhanced healing and aesthetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Barootchi, S., Tavelli, L.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20492074/

Coronally advanced flap versus connective tissue graft in ... CAF+CTG provided better CRC than CAF alone in the treatment of multiple gingival recessions at the 5-year follow-up.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1532338213001474

Coronally Advanced Flaps (CAF) Plus Connective Tissue ... Cairo et al. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. (2008).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12564554/

Modified Coronally Advanced Flaps: A Systematic Review and ... Coronally advanced flap with and without connective tissue graft for the treatment of multiple gingival recessions: A comparative short- and ...

4. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/abs/10.1002/JPER.17-0619

Long‐term evaluation (20 years) of the outcomes of ... Subepithelial connective tissue graft with coronally advanced flap (SCTG + CAF) has been considered the best and most predictable root coverage ...

5. mdpi.com mdpi.com/2304-6767/12/4/86

Treatment of Multiple RT1 Gingival Recessions Using a ... The aim of this study was to compare the effectiveness of the Coronally Advanced Flap (CAF) in RT1 (GR; gingival recession with no loss of interproximal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07064603

Clinical Evaluation of (TCAF) Versus (CAF) Combined With ... From the previous study it was concluded that the combination of both techniques in the same surgical design can improve both the flap and graft ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28338039/

Coronally advanced flap combined with connective tissue ... ResultsFifty-one RCTs were reviewed encompassing 1574 patients and 1744 recession defects. Eighty meta-analyses were conducted. Results showed that surgical ...

8. f1000research.com f1000research.com/articles/11-533

Title-comparison of coronally advanced flap with chorion ... The present study compares the clinical and patient related outcome measures of coronally advanced flap with chorion membrane and connective tissue graft