What side effects are associated with this type of intervention?

The Pinhole Surgical Technique (PST) and the Tunnel Technique are minimally invasive procedures used to treat gum recession. Common side effects of these treatments include temporary swelling, bleeding, and discomfort at the treatment site. There is also a risk of infection, though this is relatively rare with proper post-operative care. In some cases, patients may experience sensitivity in the treated areas. Both techniques aim to minimize trauma to the gum tissue, which generally results in a quicker recovery compared to more invasive surgical options.

What prior FDA approvals exist?

The FDA has approved various materials and techniques for the treatment of gum recession, including the use of acellular dermal matrix grafts and collagen membranes. These materials are often used in procedures similar to the Pinhole Surgical Technique (PST) and Tunnel Technique, which involve minimally invasive repositioning of gum tissue and subgingival placement of graft material to promote tissue regeneration and root coverage. Specific products like AlloDerm (acellular dermal matrix) and Bio-Gide (collagen membrane) have been utilized in these contexts to enhance the outcomes of periodontal surgeries.

What other types of research exist?

Promising, novel alternatives to the Pinhole Surgical Technique and Tunnel Technique for gum recession include the use of platelet-rich fibrin (PRF) and laser-assisted new attachment procedure (LANAP). PRF involves using a patient's own blood to create a fibrin matrix that promotes healing and tissue regeneration. LANAP uses laser technology to remove diseased tissue and stimulate the growth of healthy gum tissue. Both methods are minimally invasive and have shown positive outcomes in clinical studies.

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Procedure

Pinhole vs Tunnel Techniques for Gum Recession

N/A

Recruiting

Research Sponsored by Nehal Almehmadi

Eligibility Criteria Checklist

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

Must have

between 18-75 years old

have at least one non-mobile tooth with Cairo class I gingival recession of 2 to 6 mm.

Must not have

sites of gingival recession around teeth that are non-salvageable

presence of any exudate, infection or local inflammation around the area to be grafted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months (pre operative and at the 6-month follow-up visit)

Awards & highlights

Summary

This trial compares two minor surgeries for treating receding gums. It focuses on patients with this condition and aims to see which method better covers exposed roots and thickens gums by moving existing tissue.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort, swelling, bruising at the surgery site(s), temporary sensitivity to temperature or touch in treated areas, and possible infection which is rare if proper care is followed.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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

Exclusion Criteria

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months (pre operative and at the 6-month follow-up visit)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months (pre operative and at the 6-month follow-up visit)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (pre operative and at the 6-month follow-up visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in gingival recession

Change in gingival thickness

Secondary outcome measures

Aesthetic satisfaction

Change in bleeding on probing.

Change in clinical attachment.

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pinhole/TunnelExperimental Treatment1 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

0 / 4Eligibility 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

The Pinhole Surgical Technique (PST) and the Tunnel Technique are minimally invasive procedures used to treat gum recession. PST involves creating a small hole in the gum tissue through which special instruments are used to loosen and reposition the gum tissue over the exposed roots. This technique minimizes trauma and promotes faster healing. The Tunnel Technique involves creating a small tunnel in the gum tissue and inserting graft material, which is then positioned to cover the exposed roots. This method helps to stabilize the gum tissue and encourages new tissue growth. Both techniques are important for gum recession patients as they reduce sensitivity, improve aesthetics, and protect the roots from further damage, thereby enhancing overall oral health.