NCT03416673

Brief Summary

34 patients with Miller class III will be included in this study, where 17 participants will be treated with connective tissue graft with coronally advanced flap (control group) and 17 participants will be treated with a papillary extended connective tissue graft with coronally advanced flap (test group) and followed up for 6 months.

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
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

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

First Submitted

Initial submission to the registry

January 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

January 18, 2018

Last Update Submit

January 24, 2018

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Recession Depth in mm

    The vertical amount of root exposed will be measured using a UNC-15 periodontal probe

    6 months

Secondary Outcomes (6)

  • Recession Width in mm

    6 months

  • Probing depth in mm

    6 months

  • Gingival thickness in mm

    6 months

  • Width of keratinized gingiva in mm

    6 months

  • Root coverage esthetic score (Cairo et al. 2009)

    6 months

  • +1 more secondary outcomes

Study Arms (2)

CTG+CAF

ACTIVE COMPARATOR

The surgical procedure will include a connective tissue graft harvested from the palate and used under a coronally advanced flap

Procedure: CTG+CAF

peCTG+CAF

EXPERIMENTAL

A papillary extended connective tissue graft reshaped after harvested from the palate will be used under a coronally advanced flap

Procedure: peCTG+CAF

Interventions

peCTG+CAFPROCEDURE

A connective tissue graft will be reshaped to have extensions mimicking the papillae to augment the inter-dental papillae recessed

peCTG+CAF
CTG+CAFPROCEDURE

A connective tissue graft harvested from the palate will be sutured to the gingival recession site and covered with a coronally advanced flap

CTG+CAF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years or older. Periodontally and systemically healthy. Buccal recession defects classified as Miller class III. Presence of identifiable CEJ (Zucchelli et al., 2010). Clinical indication and/or patient demand for recession coverage. O'Leary index less than 20% (O'Leary et al., 1972).

You may not qualify if:

  • Miller class I, II or IV recession defects. Pregnant females. Smokers as smoking is contraindicated at any plastic periodontal surgery (Khuller, 2009).
  • Handicapped and mentally retarded patients. Teeth with cervical restorations or abrasion. Taking medication known to affect periodontal healing. Previous periodontal surgery on the involved site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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

  • Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.

    PMID: 25644302BACKGROUND

  • Kumar A, Sood V, Masamatti SS, Triveni MG, Mehta DS, Khatri M, Agarwal V. Modified single incision technique to harvest subepithelial connective tissue graft. J Indian Soc Periodontol. 2013 Sep;17(5):676-80. doi: 10.4103/0972-124X.119294.

    PMID: 24174767BACKGROUND

  • Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.

    PMID: 19335093BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Manar T Elzanaty, Master

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manar T Elzanaty, Master

CONTACT

+201001775660manar.elzanaty@dentistry.cu.edu.eg

Noha A Ghallab, Doctorate

CONTACT

+201005263365noha.ghallab@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 31, 2018

Study Start

February 1, 2018

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

January 31, 2018

Record last verified: 2018-01