Active — Not RecruitingNot Applicable

MIST Versus M-MIST for the Treatment of Intrabony Defects

Brazil50 participantsStarted 2023-08-10

Plain-language 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 diagnosed with periodontitis (Stage III/IV, Grade A or B), divided into a Test Group (n=25, Minimally invasive single-flap surgery) and a Control Group (n=25, Minimally invasive double-flap surgery). The objective of this randomized, double-blind clinical study is to compare clinical, radiographic, and patient-centered outcomes between minimally invasive single-flap and double-flap techniques in treating isolated infra-bony defects. Twenty-five patients will be treated using the single-flap approach, and 25 patients will receive the double-flap elevation technique. Clinical parameters (plaque and bleeding scores, probing depth, gingival recession, clinical attachment level, and papillary dimensions), digital measurements (changes in gingival margin and papillary volume), radiographic assessments, and patient-centered outcomes (VAS scale) will be evaluated immediately before surgery, at 6 and 12 months post-procedure, while early healing will be assessed after 1 and 2 weeks following the procedures. Mean values and standard deviations will be calculated for each variable, normal distribution will be tested using the Shapiro-Wilk test, and comparisons will be conducted using Student's t-test and one-way ANOVA. A significance level of 5% will be used for all analyses.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Probing Depth

Timeframe: 6 months and 1 year

Trial details

NCT IDNCT06058923

SponsorUniversity of Campinas, Brazil

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30