Status:
ACTIVE_NOT_RECRUITING
MIST Versus M-MIST for the Treatment of Intrabony Defects
Lead Sponsor:
University of Campinas, Brazil
Conditions:
Periodontitis
Intrabony Periodontal Defect
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This is a 12-month longitudinal, double-blind, parallel-design randomized controlled clinical trial involving surgical therapeutic intervention (Phase 4). It will include 50 participants aged 21 diagn...
Detailed Description
This is a clinical trial, a randomized controlled double-blind parallel-design study with a 12-month follow-up. Participants will be recruited from patients diagnosed with periodontitis (Stage III/IV,...
Eligibility Criteria
Inclusion
- Systemically healthy individuals
- Diagnosis of periodontitis (stage III/IV - grade A or B)
- Presence of 20 or more teeth in the oral cavity
- Presence of at least one isolated interproximal infra-bony defect (without extension of the defect to the lingual or palatal area - assessed with preoperative bone sounding), with a probing depth of 6 mm or more, and a radiographic infra-bony component ≥ 4 mm, not associated with bifurcation areas, in anterior or premolar teeth (Schincaglia et al., 2015)
- Plaque index and bleeding on probing index ≤ 20% (baseline)
- Individuals providing informed and voluntary consent
Exclusion
- Individuals who are not available for study evaluation appointments
- Systemic conditions that contraindicate periodontal surgery
- Patients requiring prophylactic antibiotics
- Compromised systemic condition (leukocyte dysfunction, bleeding disorders, neoplasms, uncontrolled metabolic or endocrine disorders, HIV infection)
- Individuals using bisphosphonates (oral or injectable use)
- Individuals using antibiotics and steroids (within 6 months prior to the study start)
- Illicit drug users
- Smokers
- Individuals with the tooth associated with the infra-bony defect having inadequate restoration, endodontic lesion, inadequate endodontic treatment, untreated carious lesions, and Grade III mobility
- Pregnant and lactating Women
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06058923
Start Date
August 10 2023
End Date
June 10 2025
Last Update
March 28 2025
Active Locations (1)
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1
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, Brazil, 13414903