Comparison of Two Flaps for Root Coverage
Evaluation of Two Different Flaps Associated With Connective Tissue Graft in the Treatment of Gingival Recession: A Randomized Clinical Trial
1 other identifier
interventional
42
0 countries
N/A
Brief Summary
The aim of this study was to compare clinical, esthetic and patient-centered outcomes of coronally advanced tunnel (TUN) and coronally advanced flap (CAF) both associated with connective tissue graft (CTG) in the treatment of gingival recession.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedResults Posted
Study results publicly available
June 7, 2017
CompletedMay 15, 2020
April 1, 2020
1.7 years
June 23, 2016
May 11, 2017
April 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Defect Coverage
Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
6 months
Secondary Outcomes (1)
Root Coverage Esthetic Score
6 months
Study Arms (2)
CAF plus connective tissue graft
ACTIVE COMPARATORCAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.
Tunnel plus connective tissue graft
EXPERIMENTALThe tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.
Interventions
Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
Eligibility Criteria
You may qualify if:
- Patients presenting Miller class I or II gingival recession in the maxillary canines or premolars
- Visible cemento-enamel junction (CEJ) with pulp vitality;
- Patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤20%;
- Patients older than 18 years old; probing depth ˂3 mm in the included teeth;
- Patients who agreed to participate and signed an informed consent form.
You may not qualify if:
- Patients presenting systemic problems that would contraindicate the surgical procedure;
- Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- Smokers or pregnant women;
- Patients who underwent periodontal surgery in the area of interest;
- Patients with orthodontic therapy in progress.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
PMID: 17309597BACKGROUNDZuhr O, Fickl S, Wachtel H, Bolz W, Hurzeler MB. Covering of gingival recessions with a modified microsurgical tunnel technique: case report. Int J Periodontics Restorative Dent. 2007 Oct;27(5):457-63.
PMID: 17990442BACKGROUNDBruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
PMID: 7928129BACKGROUNDSantamaria MP, Neves FLDS, Silveira CA, Mathias IF, Fernandes-Dias SB, Jardini MAN, Tatakis DN. Connective tissue graft and tunnel or trapezoidal flap for the treatment of single maxillary gingival recessions: a randomized clinical trial. J Clin Periodontol. 2017 May;44(5):540-547. doi: 10.1111/jcpe.12714. Epub 2017 Apr 12.
PMID: 28231619DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mauro P. Santamaria
- Organization
- Institute of Science and Technology of São José dos Campos (Unesp)
Study Officials
- PRINCIPAL INVESTIGATOR
Mauro P Santamaria, PhD
ICT-UNESP
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 27, 2016
Study Start
February 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
May 15, 2020
Results First Posted
June 7, 2017
Record last verified: 2020-04