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Completed

NCT Number: NCT03791554

Laterally Closed Tunnel VS Tunneling Technique in Recession Type 2

This study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Almanyal , Cairo, 12613, Egypt

About this study

Tunneling with subepithelial connective tissue graft:

At the recipient site (recession defect):

After scaling and root planning. A sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

At donor site (palate):

A connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision.

Then the graft is placed and secured in the recipient site using suture. The flap is displaced to be in a coronal position using a suture.

Tunneling technique with the laterally closed tunnel):

After local anesthesia, root planing of the exposed root surface will be performed. An intrasulcular incisions will be made creating a tunnel extending to the mucogingival line and mesial and distal recession defects while keeping the interdental papilla intact as well as not perforating the flap.

  • Donor SCTG Subsequently, a palatal SCTG will be harvested by means of the single incision technique with immediate closure of the donor site.
  • Recipient site; Using either single or mattress sutures, the SCTG will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Finally, the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients 18 years or older.
  • Patients with healthy systemic condition
  • Buccal recession defects with recession type 2 defects.
  • Clinical indication and/or patient request for recession coverage.
  • O'Leary index less than 20%

Exclusion criteria

  • Pregnant females.
  • Smokers as it is a contraindication for any plastic periodontal surgery
  • Unmotivated, uncooperative patients with poor oral hygiene
  • Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Treatment and study plan

Group A (Lateral closed tunnel subepithelial CT graft)

Procedure

Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the adjacent teeth to treating gingival recession with edges of the recession sutured together after placing connective tissue graft

Group B (Tunnel procedure with subepithelial CT graft)

Procedure

Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession

Other names: Autogenous sCTG will be used with tunnel procedure

Primary outcomes

  1. Reduction Recession Depth

    Time frame: 6 month

    recession depth measured from CEJ to the gingival margin in a cross-section at the central buccal site.

Secondary outcomes

  1. Gingival recession depth.

    Time frame: 6 month

    Measured as the distance between the gingival margin and the mucogingival junction

  2. Gingival recession width

    Time frame: 6 month

    Measured as the distance between the gingival margin adjacent to the defect

  3. Root coverage esthetic score (RES)

    Time frame: 6 month

    system used to evaluated five variables 6 months gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC).

  4. Probing depth

    Time frame: 6 month

    Measured from the gingival margin to the bottom of the gingival sulcus

  5. Clinical attachment level

    Time frame: 6 month

    Measured from the CEJ to the bottom of the gingival sulcus.

  6. Width of keratinized tissue

    Time frame: 6 month

    Measured as the distance between the gingival margin and the mucogingival junction

  7. Gingival thickness

    Time frame: 6 month

    The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.

  8. Post-operative pain

    Time frame: 2 weeks

    Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst' pain imaginable)

  9. Post-Surgical Patient Satisfaction Questionnaire

    Time frame: 6 month

    A 3-item questionnaire is asked and the patients shall use a 7-point answer scale. The answers were given on a 7-point scale ranging from 1 ''not at all'' to 7 ''very likely''

  10. Percentage complete root coverage

    Time frame: 6 month

    (Preoperative vertical recession -- Postoperative vertical recession/preoperative vertical recession) x 100

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Efficacy of Laterally Closed Tunnel With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Subepithelial Connective Tissue Graft in Isolated Recession Type 2; Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2019
Registry last updated
Dec 6, 2023

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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