Comparison Between Two Coronally Positioned Flap With Connective Tissue

Gingival Recession Clinical Trial

Official title:

Comparison of Two Bilaminar Techniques for Root Covering of Miller´s Recessions Class I and II: A Blind, Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01814592
• Other study ID #: PCI-2012-359
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: March 11, 2013
• Last updated: March 23, 2013
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2013
• Source: Universidad El Bosque, Bogotá
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effectiveness of total root coverage between two coronally positioned flap technique in Miller recession Class I and II, in patients attending at "Universidad El Bosque" dental school clinics.

Description:

This is a blind, randomized controlled clinical trial.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Class I and II Miller recessions showing a recession depth = 2 mm.

• Recessions isolated and / or maximum continuous two teeth.

• Recessions in incisors, canines and premolars

• Patients 20 to 60 years old.

Exclusion Criteria:

• Systemic compromise, that contraindicates any periodontal surgical procedure.

• Warfarin medication.

• Uncontrolled diabetes mellitus with glycosylated hemoglobin = 8

• Chronic steroid therapy (dose of 7.5 mg/ day for more than 14 days)

• HIV-AIDS infection with CD4 counts <200.

• Immunosuppression.

• Recessions molars not be taken into account in the study.

• Patients who have used antibiotics one month prior to the surgical procedure.

• Pregnancy.

• Active smoker.

• Patients with a history of periodontal surgery at the recession area that has taken place in the last three months.

• Severe dental malposition, teeth rotation, versions teeth root coverage that contraindicates surgery.

• Non carious cervical lesions or caries where is not visible the cemento- enamel junction (CEJ).

• Active inflammation that contraindicates surgical procedure of the recession.

• Active Orthodontics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession
• Periodontal Atrophy

Intervention

Procedure:
• coronally partial thickness flap plus connective tissue
The design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007.
• coronally mucosal thickness flap
The design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H.

Locations

Country	Name	City	State
Colombia	Universidad El Bosque	Bogotá, D. C.

Sponsors (1)

Lead Sponsor	Collaborator
Universidad El Bosque, Bogotá

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess the frequency of adverse events		0 hours (intrasurgical), 1-24 hours (immediate postoperative), 25 hours to 6 days (mediate postoperative) and 7 or more days (late postoperative)	Yes
Primary	Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque"		one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)	Yes
Secondary	Assess the proportion of root coverage		one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days)	Yes
Secondary	Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures		one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)	Yes

External Links

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