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NCT Number: NCT04513041

Pinhole Versus Tunnel for Soft Tissue Recession

This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

Each patient will undergo both surgeries on either quadrant; the PST and tunnel technique. The site will be randomized to receive either type of surgeries. Both types of surgeries are considered minimally invasive procedures to obtain root coverage for gingival recession. Both surgeries are clinically utilized in clinical practice and yield comparable results according to the literature, however, No prospective studies are published to compare between the outcomes of both techniques. patients will receive intra oral scan before the surgery and 6 months after the surgery to compare change in root coverage and gingival thickness outcomes between the two techniques. Post operative pain as well as patient satisfaction will be measured by visual analog scale and compared between the two techniques. Patients will be monitored at different time points to asses healing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • between 18-75 years old
  • have at least one non-mobile tooth with Cairo class I gingival recession of 2 to 6 mm.
  • American Society of Anesthesiology class I and II
  • full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) below 20%

Exclusion criteria

  • sites of gingival recession around teeth that are non-salvageable
  • presence of any exudate, infection or local inflammation around the area to be grafted
  • pregnant or breastfeeding females

Treatment and study plan

Pinhole surgical technique and tunnel technique in a split mouth design

Procedure

Each subject will have the each surgical procedure which are both considered routine minimally invasive clinical care for gingival recession. Gum recession on one side will receive Pinhole surgical technique (test procedure). The other side will receive Tunnel technique (control procedure), Research component involved is the capture of digital impression using intra-oral scanner in the baseline (preoperative) and the final visit (6 months postoperative).

Primary outcomes

  1. Change in gingival thickness

    Time frame: 6 months (pre operative and at the 6-month follow-up visit)

    Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival thickness.

  2. Change in gingival recession

    Time frame: 6 months (pre operative and at the 6-month follow-up visit)

    Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival recession.

Secondary outcomes

  1. Change in papillary recession

    Time frame: 6 months (pre operative and at the 6-month follow-up visit)

    Two digital scans (pre- and 6-month post-operative) will be overlapped to measure papillary gingival recession.

  2. Change in root coverage

    Time frame: 6 months (pre operative and at the 6-month follow-up visit)

    Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the complete elimination of gingival recession.

  3. Change in sulcus probing depth

    Time frame: 6 months (pre operative and at the 6-month follow-up visit)

    During a clinical exam, a sulcus will be used to measure the depth from the free gingival margin to the base of the sulcus pre- and 6-months post-operative.

  4. Change in clinical attachment.

    Time frame: 6 months (pre operative and at the 6-month follow-up visit)

    Clinical attachment will be calculated during the pre- and post-operative clinical exam.

  5. Change in zone of keratinized tissue

    Time frame: 6 months (pre operative and at the 6-month follow-up visit)

    During a clinical exam, the zone of keratinized tissue will be measured during the pre- and post-operative clinical exam.

  6. Change in bleeding on probing.

    Time frame: 6 months (pre operative and at the 6-month follow-up visit)

    The presence or absense of bleeding during probing during will be noted during the pre- and post-operative clinical exam.

  7. Post-operative pain

    Time frame: 1 week

    A Visual Analog Score for pain will be used to assess post-operative pain one week after surgery. Scores range from 0-10; higher scores indicate greater pain.

  8. Aesthetic satisfaction

    Time frame: 1 day

    A Visual Analog Score for aesthetic satisfaction will be used to assess patient satisfaction 6 months after surgery. Scores range from 0-10; higher scores indicate greater satisfaction.

Sponsors and collaborators

Lead sponsor

Mohanad Al-Sabbagh

Other

Registry information

Official study title

Comparison of Pinhole Surgical Technique and Tunnel Technique for the Treatment of Gingival Recession: A Split Mouth Clinical and Digital Study

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2020
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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