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.

Clinical and Tomographic Efficacy of the Modified Minimally Invasive Surgical Technique (M-MIST) Alone and Combined With Enamel Matrix Derivative (EMD) and Bone Mineral Derived Xenograft (BMDX), in the Treatment of Isolated, Inter-dental Intra-bony Defects

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Periodontal Bone Loss
• Intervention / Treatment: Procedure: modified minimally invasive surgical technique; Procedure: modified minimally invasive surgical technique plus emdogain; Procedure: modified minimally invasive surgical technique plus emdogain and xenograft

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chhattisgarh
    • Bhilai, Chhattisgarh, India, 490023
      • Department of Periodontics, Rungta College of Dental Sciences and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: modified minimally invasive surgical technique	Procedure: modified minimally invasive surgical technique; modified minimally invasive surgical technique alone in interdental area
Active Comparator: modified minimally invasive surgical technique with emdogain	Procedure: modified minimally invasive surgical technique plus emdogain; modified minimally invasive surgical technique with application of enamel matrix proteins in interdental area
Experimental: modified minimally invasive surgical technique with emdogain and xenograft	Procedure: modified minimally invasive surgical technique plus emdogain and xenograft; modified minimally invasive surgical technique with application of enamel matrix proteins and placement of bovine bone graft in interdental area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full mouth plaque score	Turesky Modification of Quigley-Hein Index used to assess plaque buildup across all tooth surfaces (buccal, lingual, mesial, distal) with scoring 0 (no plaque) to 5 (heavy plaque)	24 weeks
Full mouth bleeding score	Probe is inserted and withdrawn at the distal point of the tooth and monitored for bleeding within 10 seconds. Registered with (+) availability of provoked bleeding and with (-) its absence.	24 weeks
Mean defect depth	measured as the distance fromt the alveolar crest to the base of the defect (in CBCT)	24 weeks

Collaborators and Investigators

• Sponsor: Rungta College of Dental Sciences and Research

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss; Periodontal Diseases; Surgical Procedures, Operative; Transplantation; Transplantation, Heterologous; enamel matrix proteins
• Other Study ID Numbers: RCDSR/IEC/MDS/2021/b-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes