Back to resultsMicrosurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
Primary Purpose
Gingival Recession, Mucogingival Surgery
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Mucogingival Surgery
Eligibility Criteria
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
Sites / Locations
- Cukurova University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
laterally moved coronally advanced flap microsurgical
laterally moved coronally advanced flap macrosurgical
Arm Description
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 .
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.
Outcomes
Primary Outcome Measures
the percentage of root coverage
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02281071
Brief Title
Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
Official Title
Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Mucogingival Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laterally moved coronally advanced flap microsurgical
Arm Type
Experimental
Arm Description
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 .
Arm Title
laterally moved coronally advanced flap macrosurgical
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe
Intervention Description
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.
Primary Outcome Measure Information:
Title
the percentage of root coverage
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01330
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
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