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NCT Number: NCT06646432

Treatment of Gingival Recession With Tunnel Technique Using Connective Tissue Graft and Injectable Platelet Rich Fibrin

Gingival recession is a common periodontal problem. Consequences include teeth sensitivity, poor esthetics and impaired oral hygiene access. Mild cases are managed by optimizing oral hygiene measures, correction of any causative factor such as faulty tooth brushing, improper dental restoration or denture clasp. Prescription of desensitization products such as specific tooth gels or mouth washes can manage the sensitivity problem. Deeper recession defects need to be addressed by surgical procedures. Coronally advanced flap with connective tissue graft is the gold standard procedure. However, it has some drawbacks due to the need for papillary incisions and vertical incisions in some cases. Within the era of minimally invasive periodontology, tunnel technique with connective tissue graft showed results comparable to coronally advanced flap with connective tissue graft but with some limitations. Addition of another agent may enhance the results of tunnel technique. Injectable platelet rich fibrin is known for its content of growth factors and effects on soft tissue healing. Aim: The study aim is to compare the surgical management of gingival recession with tunnel technique using connective tissue graft and injectable platelet rich fibrin to tunnel with connective graft without injectable platelet rich fibrin.

Methodology: 30 patients with miller class I or II gingival recession will be enrolled. 15 in the test group (Tunnel+ CTG+ i-PRF) and 15 in control group (Tunnel+ CTG). Clinical evaluation at 6 months

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Suez canal university

Ismailia, 41522, Egypt

Location status: Recruiting

Location contact

Abdelaziz

CONTACT

[email protected]

002+ 01118580817

About this study

30 patients with miller class I/II gingival recession will be enrolled in this study.

15 patients will be treated using tunnel technique and palatal connective tissue graft inserted and sutured under the prepared tunnel after being soaked in injectable platelet rich fibrin for 15 minutes. The tunnel with the underlying graft will be advanced coronally. (Test Group) The other 15 patients will be treated the same way as in the first group but without soaking the graft in injectable platelet rich fibrin. (Control Group) Clinical parameters will be evaluated at baseline and 6 months follow-up except post-operative pain which will be assessed after 10 days. Histologic examination of small piece of the graft will be done to assess if there is true saturation of growth factors inside the graft.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • More than 21 years old
  • Systemically healthy
  • Presence of Miller class I/II gingival recession
  • Presence of identifiable CEJ

Exclusion criteria

  • Smoking
  • Systemic disease that contraindicates surgical procedures.
  • Poor compliance with oral hygiene measures
  • Necrotizing gingival conditions
  • Ongoing active periodontitis

Treatment and study plan

Tunnel with connective tissue graft and injectable platelet rich fibrin

Procedure

Tunnel with connective tissue graft and injectable platelet rich fibrin

Tunnel with connective tissue graft only

Procedure

Tunnel technique with connective tossue graft only without injectable platelet rich fibrin

Primary outcomes

  1. Recession depth

    Time frame: 6 months after the surgery

    it will be recorded as the distance between the CEJ and gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.

  2. Keratinized tissue height

    Time frame: 6 months

    It will be measured from the mucogingival junction to the gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.

  3. Gingival thickness

    Time frame: 6 months

    It will be measured at a mid-buccal location 1 mm apical to the probing depth level with an spreader. It will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface. Penetration depth will be measured.

Secondary outcomes

  1. Post operative pain

    Time frame: 10 days

    It will be measured by Visual analog Scale (VAS) with records from 0 to 10 with 0 means no pain and 10 means very severe pain. The patient will report the degree he experienced pain and choose a score from VAS.

  2. Recession width

    Time frame: 6 months

    It will be measured horizontally between the borders of the recession at the level of Cemento-enamel Junction.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Abdel-aziz

CONTACT

[email protected]

00201118580817

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Treatment of Gingival Recession by Tunnel Technique Using Connective Tissue Graft With or Without Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Jan 29, 2025

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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