- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02281071
Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Adana, Turkey, 01330
- Cukurova University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 nasıl oluştu demiş 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: laterally moved coronally advanced flap microsurgical
For the test group (LMCAF-M), the surgical procedures were performed with the aid of a galilean loupe, under 2.5x magnification vision, microsurgical instruments and microsurgical suture material .
|
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.
|
Active Comparator: laterally moved coronally advanced flap macrosurgical
For the control group (LMCAF), LMCAF was performed with conventional instruments (detaylı) and materials (stur).
Loupe magnification, microsurgical instruments and suture material were not used in the control group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the percentage of root coverage
Time Frame: at 6 months
|
at 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CukurovaU2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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