ClinicalTrials.gg
Status unknownNCT02642887Updated Dec 30, 2015

A Modified Tunnel Approach in Treatment of Gingival Recession

An interventional study of mTA + SCTG in Gingival Recession, sponsored by Al-Azhar University. Status unknown. Open to participants aged 29 Years to 47 Years. Per ClinicalTrials.gov, last updated 2015-12-30.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
29 Years to 47 Years
Sex
All
01

Study summary

Objectives: To clinically evaluate the healing of Miller Class I and II isolated gingival recessions treated with the modified tunnel approach (mTA) versus the conventional tunnel technique (cTT) in conjunction with subepithelial connective tissue graft (SCTG).

Material and Methods: In this split-mouth study, thirty healthy patients exhibiting two isolating anterior Miller Class I and II gingival recessions were treated with mTA + SCTG and cTT + SCTG. Treatment outcomes were assessed at baseline, 3-months and 6-months postoperatively. The primary outcome was root coverage esthetic scores (RES).

Read the detailed description

Various techniques have been suggested for the treatment of isolated mandibular recessions e.g., envelope, coronally advanced flaps double pedicle flap or tunneling procedures combined with laterally positioned pedicle flaps in conjunction with SCTG. Despite the fact that the mentioned techniques appear to improve root coverage, the success in terms of complete root coverage has high variability and thus it is still unknown which approach may lead to the most predictable outcomes. The limited evidence from the literature points clearly to the clinical importance of developing new concepts for predictable of isolated mandibular recessions.

The MTA is a dual flap approach; that starts with full thickness flap (avoiding papilla incision) till the level of the mucogingival junction. On reaching the level of the vestibular mucosa, a partial thickness flap is applied to undermine the base of the flap. Using this dual approach carries two main advantages: avoidance of severing the gingival blood supply through the full thickness flap, in addition to minimizing the tension on the flap tissue through using the partial thickness flap at the above-mentioned site.

In this trial, the mTA has been proposed for the surgical treatment of isolated mandibular recessions due to the following advantages: 1) it avoids vertical releasing incisions. 2) it doesn't incise the papilla, which may improve the vascularization of the area plus stabilizing the soft tissue flap. 3) it is suitable to patients with thin gingival biotype.

02

Conditions studied

  • Gingival Recession

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Keywords

  • gingival recession
  • tunnel technique
  • Miller Class I and II
03

In context

Gingival Recession

413 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.

This study's enrollment of 30 is close to the median of 30 across 379 interventional studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 525 studies on the registry; 171 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Years to 47 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • except for chronic periodontitis, our patients were systemically free
  • Two mandibular Miller Class I or II recession sites
  • at least 2 mm attached gingiva.
  • at least 3 mm depth of recession.

Exclusion criteria

Exclusion Criteria:

  • Systemic diseases.
  • Smokers or formal smokers
  • Pregnant or lactating females
  • History of antibiotic therapy at the last 6 months
  • Patients who are not willing to follow the study protocol
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    The test group

    This group included 30 recession defects treated with mTA + SCTG

    Procedure: mTA + SCTG

  • No intervention
    The control group

    This group included 30 recession defects treated with cTT + SCTG

Interventions

  • ProceduremTA + SCTG

    These recession defects will be covered by modified tunnel approach; using a full thickness flap till the level of mucogingival junction then, partial thickness flap will be applied in the vestibular mucosa. SCTG will be harvested from the palate, put on the root surface then covered by the mTA and sutured.

    Also known as: Dual approach + SCTG

06

What researchers measure

Primary outcomes

  1. The change in Root Coverage Esthetic Score

    This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. It is calculated by expert operator.

    Time frame: Baseline, 3 months and 6 months

Secondary outcomes

  1. The change in percentage of root coverage

    The percentage of root coverage will be calculated at 3 months, then 6 months.

    Time frame: Baseline, 3 months and 6 months

  2. The change in depth of gingival recession

    The change in depth of gingival recession will be calculated at baseline, 3 months and 6 months.

    Time frame: Baseline, 3 months and 6 months.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182. PubMed 24641000 ↗
  • Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28. PubMed 22639845 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02642887
Responsible party
Hala Helmi Hazzaa (Assistant Professor, Al-Azhar University) — Principal investigator
First posted
Dec 30, 2015
Start date
Mar 2015
Primary completion
Jan 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Dec 30, 2015

Study contacts

Hala H Hazzaa, Professor
principal investigator · Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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