NCT02281071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

October 30, 2014

Last Update Submit

October 31, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • the percentage of root coverage

    at 6 months

Study Arms (2)

laterally moved coronally advanced flap microsurgical

EXPERIMENTAL

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 .

Procedure: laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe

laterally moved coronally advanced flap macrosurgical

ACTIVE COMPARATOR

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.

Procedure: laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe

Interventions

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.

laterally moved coronally advanced flap macrosurgicallaterally moved coronally advanced flap microsurgical

Eligibility Criteria

Age22 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor doctor PhD

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 3, 2014

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

October 1, 2014

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations