MIST Versus M-MIST for the Treatment of Intrabony Defects

NCT06058923 | Active Not Recruiting

• 1 other identifier: 69036023.5.0000.5418
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Periodontitis; Intrabony Periodontal Defect; Periodontitis, Chronic

Outcome Measures

Primary Outcomes (1)

• Probing Depth

  Reduction of Probing Depth

  6 months and 1 year

Secondary Outcomes (2)

• Clinical Attachment Level

  6 months and 1 year

• Subtraction Radiography

  1 year

Study Arms (2)

Minimally Invasive Surgical Technique (MIST)

ACTIVE COMPARATOR

Double flap minimally invasive surgery for the access of intrabony defects

Procedure: MIST

Modified Minimally Invasive Surgical Technique (M-MIST)

EXPERIMENTAL

Single flap minimally invasive surgery for the access of intrabony defects

Procedure: M-MIST

Interventions

M-MIST PROCEDURE

This is characterized by a vestibular mucoperiosteal envelope flap without relaxing incisions. Sulcular incisions will be made on the vestibular surface of the teeth included in the surgical area, adjacent to the infraosseous defect. The mesiodistal extension of the flap will be kept to a minimum necessary to access the defect. In the papillary area over the infraosseous defect, an oblique or horizontal incision will be made at the level of the interdental papilla, following the contour of the bone crest. The vestibular flap will be elevated, leaving the lingual/palatal portion adhered, only to allow access to the bone defect. The defect will be instrumented with mini-curettes and specific ultrasonic tips, and the defect will be filled only with a blood clot after this procedure. Primary closure will be achieved with internal vertical and/or horizontal mattress sutures, which may be complemented with simple sutures, all using specific suture threads.

Also known as: Minimally invasive single flap technique

Modified Minimally Invasive Surgical Technique (M-MIST)

MIST PROCEDURE

A vestibular envelope flap, without vertical relaxing incisions, will be raised on the vestibular and lingual/palatal sides. Primary intrasulcular incisions will be made to the alveolar crest, encompassing the teeth included in the surgical area. In the interproximal area, incisions will follow the principle of preserving the papilla (Modified Papilla Preservation Technique = MPPT or Simplified Papilla Preservation Flap = SPPF), depending on the available interproximal space (Cortellini et al., 1995, 1999). The mesiodistal extension of the flap will be minimized to provide adequate access to the defect. The defect will be instrumented using mini-curettes and specific ultrasonic tips, and the defect will be filled only with a blood clot after these procedures. Flap closure will be achieved with internal horizontal and/or vertical mattress sutures, which may be modified or complemented with simple sutures, all using specific suture threads.

Also known as: Minimally invasive double flap technique

Minimally Invasive Surgical Technique (MIST)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414903, Brazil

Location

MeSH Terms

Conditions

Periodontitis; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thais FM Paschoal, MsC

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Chair of Periodontology Area

Model Details: Randomized controlled double-blind parallel-design clinical trial with a longitudinal duration of 12 months per participant, involving surgical therapeutic intervention.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

BR (1)