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Effectiveness of the Papillary Extended Connective Tissue Graft in Miller Class III Gingival Recession

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416673
Recruitment Status : Unknown
Verified January 2018 by Manar El-Zanaty, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Manar El-Zanaty, Cairo University

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.

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: peCTG+CAF Procedure: CTG+CAF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness of Coronally Advanced Flap With Papillary Extended Connective Tissue Graft Versus Connective Tissue Graft in Miller Class III Recession: A Randomized Clinical Trial
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Active Comparator: CTG+CAF
The surgical procedure will include a connective tissue graft harvested from the palate and used under a coronally advanced flap
Procedure: CTG+CAF
A connective tissue graft harvested from the palate will be sutured to the gingival recession site and covered with a coronally advanced flap

Experimental: peCTG+CAF
A papillary extended connective tissue graft reshaped after harvested from the palate will be used under a coronally advanced flap
Procedure: peCTG+CAF
A connective tissue graft will be reshaped to have extensions mimicking the papillae to augment the inter-dental papillae recessed




Primary Outcome Measures :
  1. Recession Depth in mm [ Time Frame: 6 months ]
    The vertical amount of root exposed will be measured using a UNC-15 periodontal probe


Secondary Outcome Measures :
  1. Recession Width in mm [ Time Frame: 6 months ]
    The width of the exposed root will be measured using a UNC-15 periodontal probe

  2. Probing depth in mm [ Time Frame: 6 months ]
    Measured from the gingival margin to the base of the sulcus will be measured using a UNC-15 periodontal probe

  3. Gingival thickness in mm [ Time Frame: 6 months ]
    the thickness of the gingival tissues will be measured by piercing the gingiva till touching bone with a #15 endodontic reamer under anethesia

  4. Width of keratinized gingiva in mm [ Time Frame: 6 months ]
    from the gingival margin to the mucogingival junction will be measured using a UNC-15 periodontal probe

  5. Root coverage esthetic score (Cairo et al. 2009) [ Time Frame: 6 months ]
    evaluation of the esthetic outcomes of root coverage procedures according to Cairo et al. 2009 Root Coverage Esthetic Score

  6. Patient satisfaction (Kim et al. 2014) [ Time Frame: 6 months ]
    measuring the degree of satisfaction of the patients according to Kim et al. 2014 questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416673


Contacts
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Contact: Manar T Elzanaty, Master +201001775660 manar.elzanaty@dentistry.cu.edu.eg
Contact: Noha A Ghallab, Doctorate +201005263365 noha.ghallab@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Manar T Elzanaty, Master Cairo University
Publications:
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Responsible Party: Manar El-Zanaty, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03416673    
Other Study ID Numbers: peCTG-MC3
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy