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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02281071
Other study ID # CukurovaU2
Secondary ID
Status Completed
Phase N/A
First received October 30, 2014
Last updated October 31, 2014
Start date January 2012
Est. completion date October 2014

Study information

Verified date October 2014
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

The benefits of microsurgical approaches in periodontal therapy have been described. The main focus of this study is to determine if using microsurgical LMCAF technique would improve the outcomes of the therapy for the Miller Class III isolated recession-type defects.

Six months results of this study showed that LMCAF with microsurgical approach offered better complete and mean root coverage results over macrosurgical LMCAF technique. The superior effect of microsurgical approach on post-operative morbidity can make this technique more preferable for the patients who expected comfortable postoperative period.

This study supports that using the microsurgical aproach with LMCAF procedure significantly affects the clinical and patient-centered success of treating Miller Class III isolated typed defects.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2014
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 22 Years to 39 Years
Eligibility Inclusion Criteria:

- Presence of Miller Class III isolated gingival recessions located at upper and lower incisors and canines (Miller 1985)

- Presence of identifiable cementoenamel junction (CEJ)

- Presence of a step = 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ

- Lateral keratinized tissue width at least 6 mm greater than the width of the recession measured at the level of the cemento-enamel junction (CEJ)

- Lateral keratinized tissue height at least 2 mm greater than the buccal probing depth of the adjacent tooth/teeth

- Full-mouth plaque score and full-mouth bleeding score of < 15% (four sites/tooth) -No occlusal interferences; all patients were nonsmokers

Exclusion Criteria:

- Tooth with a prosthetic crown or restoration involving CEJ

- Patients with a history of destructive periodontal disease (o zaman class 3 nasil olustu demis adam) or repeated abscess formation

- Presence of systemic disease or taking medications known to interfere with periodontal tissue health or healing (patients with insulin-dependent diabetes

- History of malignancy, radiotherapy, or chemotherapy for malignancy

- Disease affecting connective tissue metabolism)

- Patient pregnant or nursing during the past 5 months

- Patients who participated in a clinical trial within the past 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe
The recipient area for the laterally moved flap was prepared. When the flap was moved in the distal-mesial direction another short horizontal incision was performed at the most apical extension of this vertical incision. Once the mucogingival line was reached, flap elevation was continued split-thickness. Flap elevation was terminated when it was possible to passively move the flap laterally above the exposed root. Flap was sutured.

Locations

Country Name City State
Turkey Cukurova University Adana

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary the percentage of root coverage at 6 months Yes