Clinical and Radiographic Assessment of Efficacy of Modified Minimally Invasive SurgicalTechnique (M-MIST) Alone and Combined With Enamel Matrix Proteins and Ox-derived Bone Graft in the Treatment of Single Bone Defects Between Teeth.

NCT07310732 | Completed

• 1 other identifier: RCDSR/IEC/MDS/2021/b-11
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study was performed to investigate the adjunctive clinical benefit of the application of enamel matric derivatives and xenograft with the modified minimally invasive surgical technique in the treatment of isolated intrabony defects in periodontally compromised subjects.

Conditions

Periodontal Diseases; Periodontal Bone Loss

Outcome Measures

Primary Outcomes (2)

• Probing Pocket Depth

  The depth of probe penetration into the pocket (millimeters) is measured from the gingival margin using an UNC-15 probe.

  24 weeks

• Clinical Attachment Level

  The distance from the base of the pocket to cemento-enamel junction (millimeters) is measured using an UNC-15 probe.

  24 weeks

Secondary Outcomes (3)

• Full mouth plaque score

  24 weeks

• Full mouth bleeding score

  24 weeks

• Mean defect depth

  24 weeks

Study Arms (3)

modified minimally invasive surgical technique

PLACEBO COMPARATOR

Procedure: modified minimally invasive surgical technique

modified minimally invasive surgical technique with emdogain

ACTIVE COMPARATOR

Procedure: modified minimally invasive surgical technique plus emdogain

modified minimally invasive surgical technique with emdogain and xenograft

EXPERIMENTAL

Procedure: modified minimally invasive surgical technique plus emdogain and xenograft

Interventions

modified minimally invasive surgical technique PROCEDURE

modified minimally invasive surgical technique alone in interdental area

modified minimally invasive surgical technique

modified minimally invasive surgical technique plus emdogain PROCEDURE

modified minimally invasive surgical technique with application of enamel matrix proteins in interdental area

modified minimally invasive surgical technique with emdogain

modified minimally invasive surgical technique plus emdogain and xenograft PROCEDURE

modified minimally invasive surgical technique with application of enamel matrix proteins and placement of bovine bone graft in interdental area

modified minimally invasive surgical technique with emdogain and xenograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least one site associated with an intrabony defect of ≥3 mm involving predominantly the interdental space of the tooth
• patients with optimal compliance

You may not qualify if:

• Patients with uncontrolled or poorly controlled diabetes
• history of long-term use of medications
• allergic to medications
• pregnant or lactating women
• smokers/users of other tobacco products

Sponsors & Collaborators

• Rungta College of Dental Sciences and Research: lead

Study Sites (1)

Department of Periodontics, Rungta College of Dental Sciences and Research

Bhilai, Chhattisgarh, 490023, India

Location

Related Publications (4)

• Cortellini P, Tonetti MS. Clinical and radiographic outcomes of the modified minimally invasive surgical technique with and without regenerative materials: a randomized-controlled trial in intra-bony defects. J Clin Periodontol. 2011 Apr;38(4):365-73. doi: 10.1111/j.1600-051X.2011.01705.x. Epub 2011 Feb 8.

  PMID: 21303402 BACKGROUND

• Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human infrabony defects. II. Re-entry procedures and bone measures. J Periodontol. 1993 Apr;64(4):261-8. doi: 10.1902/jop.1993.64.4.261.

  PMID: 8483088 BACKGROUND

• Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human infrabony defects. I. Clinical measures. J Periodontol. 1993 Apr;64(4):254-60. doi: 10.1902/jop.1993.64.4.254.

  PMID: 8483087 BACKGROUND

• Camelo M, Nevins ML, Lynch SE, Schenk RK, Simion M, Nevins M. Periodontal regeneration with an autogenous bone-Bio-Oss composite graft and a Bio-Gide membrane. Int J Periodontics Restorative Dent. 2001 Apr;21(2):109-19.

  PMID: 11829385 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Alveolar Bone Loss

Interventions

enamel matrix proteins; Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 30, 2025
• Study Start: March 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

IN (1)