NCT02642887

Brief 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

December 18, 2015

Last Update Submit

December 26, 2015

Conditions

Gingival Recession

Keywords

gingival recessiontunnel techniqueMiller Class I and II

Outcome Measures

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.

    Baseline, 3 months and 6 months

Secondary Outcomes (2)

  • The change in percentage of root coverage

    Baseline, 3 months and 6 months

  • The change in depth of gingival recession

    Baseline, 3 months and 6 months.

Study Arms (2)

The test group

EXPERIMENTAL

This group included 30 recession defects treated with mTA + SCTG

Procedure: mTA + SCTG

The control group

NO INTERVENTION

This group included 30 recession defects treated with cTT + SCTG

Interventions

mTA + SCTGPROCEDURE

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
The test group

Eligibility Criteria

Age29 Years - 47 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 24641000BACKGROUND

  • 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.

    PMID: 22639845BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Hala H Hazzaa, Professor

    Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 18, 2015

First Posted

December 30, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

December 30, 2015

Record last verified: 2015-12