Pinhole vs Tunnel Techniques for Gum Recession

Overseen By Mohanad Al-Sabbagh, BDS (DDS)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nehal Almehmadi

Disqualifiers: Non-salvageable teeth, Infection, Pregnancy

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two techniques to address gum recession, a condition where gums recede and expose more of the teeth. The trial aims to determine whether the pinhole surgical technique (also known as the Chao Pinhole Surgical Technique or PST) or the tunnel technique (also known as the Tunneling technique) is more effective for covering exposed tooth roots and thickening gum tissue. Participants will receive one technique on one side of their mouth and the other technique on the opposite side. Suitable candidates for this trial have experienced gum recession of 2 to 6 mm on at least one tooth and do not have infections or significant plaque and bleeding issues. As an unphased trial, this study allows participants to contribute to dental research and potentially benefit from innovative treatments for gum recession.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these surgical techniques are safe for treating gum recession?

Research has shown that both the pinhole surgical technique (PST) and the tunnel technique safely treat gum recession. Studies indicate that the pinhole technique is less invasive and highly successful. Specifically, one study found a 96.7% success rate in covering exposed roots, with 95% of patients satisfied with the results. This method involves making a small opening in the gum and gently moving the tissue to cover the exposed roots, without adding extra tissue.

The tunnel technique has also proven safe and effective for treating gum recession. Patients using this method have experienced reliable results. It involves repositioning the gum tissue over the exposed roots, similar to other successful methods, and is known for achieving good outcomes.

Both techniques are generally well-tolerated, with serious side effects being rare. Participants in studies have reported minimal discomfort, making these techniques promising options for those dealing with gum recession. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pinhole and Tunnel techniques for gum recession because these methods offer less invasive alternatives to traditional gum grafting. Unlike conventional treatments that require tissue grafts from the roof of the mouth, both techniques aim to correct gum recession with minimal cutting and suturing. The Pinhole technique involves creating a small entry point to loosen and reposition the gum tissue, while the Tunnel technique uses a similar concept but with a different approach to access and move the gums. These methods potentially reduce recovery time and discomfort, making them attractive options for patients seeking less painful and quicker solutions to gum recession.

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

This trial will compare the effectiveness of the pinhole surgical technique (PST) and the tunnel technique for treating gum recession. Studies have shown that PST is very effective, with research indicating it can cover up to 94% of the exposed tooth root. It offers a lasting solution without the need for cutting or stitches. Similarly, the tunnel technique has proven effective for gum recession, particularly useful for treating multiple areas and providing reliable results. Participants in this trial will receive PST on one side of the mouth and the tunnel technique on the other, allowing for a direct comparison of these dependable options for improving gum health. ^{1 2 6 7 8}

Who Is on the Research Team?

Mohanad Al-Sabbagh

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with mild to moderate gum recession on at least one stable tooth, who are generally healthy (ASA class I and II) and have good oral hygiene (low plaque and bleeding scores). Pregnant or breastfeeding individuals, those with infected gums around the affected area, or teeth that can't be saved are excluded.

Inclusion Criteria

American Society of Anesthesiology class I and II

full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) below 20%

I have a tooth with gum recession between 2 to 6 mm.

Exclusion Criteria

I have severe gum recession around teeth that cannot be saved.

pregnant or breastfeeding females

The area for my graft does not have any infection, swelling, or discharge.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Pinhole surgical technique and Tunnel technique for treatment of soft tissue recession

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative pain and healing progress

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in gingival thickness, root coverage, and other outcomes

6 months

1 visit (in-person) at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Pinhole surgical technique
• Tunnel technique

Trial Overview

The study compares two surgical methods for treating gum recession without using patient's own tissue: the pinhole surgical technique (PST) and tunnel technique. Each participant will receive both treatments in different areas of their mouth randomly.

How Is the Trial Designed?

Group I: Pinhole/Tunnel Experimental Treatment 1 Intervention

Participants will receive Pinhole surgical technique for treatment of soft tissue recession at one side of the mouth and Tunnel technique for treatment of soft tissue recession at the other side of the mouth

Pinhole surgical technique is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Chao Pinhole Surgical Technique for:

• Gum recession
• Soft tissue recession

Approved in European Union as Chao Pinhole Surgical Technique for:

• Gum recession
• Soft tissue recession

Approved in Canada as Chao Pinhole Surgical Technique for:

• Gum recession
• Soft tissue recession

Who Is Running the Clinical Trial?

Nehal Almehmadi

Lead Sponsor

Trials

1

Recruited

30+

Mohanad Al-Sabbagh

Lead Sponsor

Trials

2

Recruited

50+

Published Research Related to This Trial

The pinhole surgical technique (PST) for root coverage showed a high predictability of 81.2% for Class I and II recession sites, with a mean defect reduction of 94.0%, making it a promising alternative to traditional graft techniques.

PST is minimally invasive, requiring only a small incision and no secondary surgical site, with a mean procedure time of 22.3 minutes and high patient satisfaction at 95.1%, indicating its potential for effective and efficient treatment of gum recession.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to root coverage: the pinhole surgical technique. Chao, JC.[2013]

In a study involving 12 patients with localized gingival recession, the tunnel technique combined with thin connective tissue grafts resulted in a slightly greater reduction in gum recession compared to thick grafts, but the difference was not statistically significant after 6 months.

Both treatment methods achieved similar outcomes in terms of complete root coverage, gingival thickness, aesthetic scores, and patient-reported pain levels, indicating that thin grafts can be as effective as thick grafts for this dental procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of graft thickness on tunnel technique procedures for root coverage: a pilot split-mouth randomized controlled trial. Teodoro de Carvalho, VA., Mattedi, MAM., Vergara-Buenaventura, A., et al.[2023]

Connective tissue grafting combined with the tunnel procedure is an effective method for managing gingival recession defects, allowing for root coverage in a single operation and showing positive histological evidence of periodontal regeneration in human subjects.

Clinical trials indicate that this technique results in early tissue healing, improved blood supply, and excellent aesthetic outcomes, making it a favorable option for patients and enhancing the success rate of root coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A promising periodontal procedure for the treatment of adjacent gingival recession defects. Tözüm, TF.[2005]

In a study involving 12 healthy patients with multiple gum recession defects, the minimally invasive coronally advanced tunnel technique (MI-CAT) with orthodontic buttons and suturing resulted in a higher complete root coverage rate of 73% compared to 56% in the control group after 6 months.

Both the test and control groups achieved similar aesthetic scores for root coverage, indicating that MI-CAT is an effective and predictable method for treating gum recession without compromising aesthetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Multiple Gingival Recessions Using a Minimally Invasive Coronally Advanced Tunnel: A Randomized Controlled Clinical Trial. Khanna, D., George, JP., Babrawala, IS., et al.[2022]

The study involved 165 patients with multiple adjacent gingival recession defects, comparing the effectiveness of pinhole surgical technique (PST) alone versus PST combined with advanced platelet rich fibrin (A-PRF).

Results showed that the combination of PST with A-PRF significantly improved clinical outcomes, including greater reductions in gingival recession depth and width, as well as increased keratinized tissue width and gingival thickness, compared to PST alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of pinhole surgical technique with and without A-PRF in the treatment of multiple adjacent recession defects: A clinico radiographic study. Trivedi, DS., Kolte, AP., Kolte, RA., et al.[2023]

The tunnel technique for treating localized and multiple gingival recessions has been shown to be effective, as demonstrated by a systematic review and meta-analysis, which consolidates data from various studies.

This technique not only improves the aesthetic appearance of the gums but also promotes better healing outcomes, making it a valuable option for periodontal treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tunneling Technique in Conjunction With Autogenous Graft or Graft Substitutes Is a Predictable Surgical Approach to Achieve Root Coverage in Isolated or Multiple Gingival Recession Defects. Elangovan, S.[2020]

The Tunnel technique (TUN) shows promising effectiveness for treating gingival recession, achieving an average root coverage of about 82.75% for localized defects and 87.87% for multiple defects, particularly in maxillary areas and lower Miller Class defects.

While TUN and the Coronally Advanced Flap (CAF) procedures yield similar results in terms of root coverage and esthetic outcomes, CAF tends to provide better complete root coverage when the same graft materials are used, suggesting that CAF may be the superior option in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tunnel technique in the treatment of localized and multiple gingival recessions: A systematic review and meta-analysis. Tavelli, L., Barootchi, S., Nguyen, TVN., et al.[2022]

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Effectiveness of PST for Class I and II sites, measured as mean percent defect reduction, was 94.0% ± 14.8%. When data from Class I, II, and III sites were ...

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Pinhole Surgical Technique

It involves creating a tiny pinhole in the gum tissue, gently repositioning it over exposed tooth roots without grafting, achieving natural looking results ...