Periodontal DiseasesNCT07310732
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.
A study testing modified minimally invasive surgical technique, modified minimally invasive surgical technique plus emdogain and modified minimally invasive surgical technique plus emdogain and xenograft in people with Periodontal Diseases and Periodontal Bone Loss, run by Rungta College of Dental Sciences and Research at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases, Periodontal Bone Loss
- What is being tested?
- modified minimally invasive surgical technique, modified minimally invasive surgical technique plus emdogain and modified minimally invasive surgical technique plus emdogain and xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least one site associated with an intrabony defect of ≥3 mm involving predominantly the interdental space of the tooth
- patients with optimal compliance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Periodontics, Rungta College of Dental Sciences and Research
Bhilai, Chhattisgarh, 490023
About this study
Official title: 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.
- Conditions
- Periodontal Diseases, Periodontal Bone Loss
- Being tested
- modified minimally invasive surgical technique, modified minimally invasive surgical technique plus emdogain, modified minimally invasive surgical technique plus emdogain and xenograft
- Medical subject headings
- Periodontal Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified minimally invasive surgical techniqueProcedure or surgery
modified minimally invasive surgical technique alone in interdental area
modified minimally invasive surgical technique plus emdogainProcedure or surgery
modified minimally invasive surgical technique with application of enamel matrix proteins in interdental area
modified minimally invasive surgical technique plus emdogain and xenograftProcedure or surgery
modified minimally invasive surgical technique with application of enamel matrix proteins and placement of bovine bone graft in interdental area
| Study group | Role | What they receive |
|---|---|---|
| modified minimally invasive surgical technique | Placebo comparator | Not described Receives: Procedure: modified minimally invasive surgical technique |
| modified minimally invasive surgical technique with emdogain | Active comparator | Not described Receives: Procedure: modified minimally invasive surgical technique plus emdogain |
| modified minimally invasive surgical technique with emdogain and xenograft | Experimental | Not described Receives: Procedure: modified minimally invasive surgical technique plus emdogain and xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth
The depth of probe penetration into the pocket (millimeters) is measured from the gingival margin using an UNC-15 probe.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (3)
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)
Measured: 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.
Measured: 24 weeks
Mean defect depth
measured as the distance fromt the alveolar crest to the base of the defect (in CBCT)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Mar 2022
- Primary completion1 Sep 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rungta College of Dental Sciences and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Krishna M, Rungta College of Dental Sciences and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310732
- Sponsor's protocol ID
- RCDSR/IEC/MDS/2021/b-11
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 21303402Cortellini 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.
PubMed 8483088Cortellini 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.
PubMed 8483087Camelo 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.
PubMed 11829385
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07310732
- Acronym / sponsor ID
- RCDSR/IEC/MDS/2021/b-11
- Conditions
- Periodontal Diseases, Periodontal Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Rungta College of Dental Sciences and ResearchUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least one site associated with an intrabony defect of ≥3 mm involving predominantly the interdental space of the tooth
- patients with optimal compliance
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified minimally invasive surgical techniquemodified minimally invasive surgical technique alone in interdental area | Procedure or surgery | modified minimally invasive surgical technique |
| modified minimally invasive surgical technique plus emdogainmodified minimally invasive surgical technique with application of enamel matrix proteins in interdental area | Procedure or surgery | modified minimally invasive surgical technique with emdogain |
| modified minimally invasive surgical technique plus emdogain and xenograftmodified minimally invasive surgical technique with application of enamel matrix proteins and placement of bovine bone graft in interdental area | Procedure or surgery | modified minimally invasive surgical technique with emdogain and xenograft |
Primary outcome
Probing Pocket Depth
Time frame: 24 weeks
The depth of probe penetration into the pocket (millimeters) is measured from the gingival margin using an UNC-15 probe.
Clinical Attachment Level
Time frame: 24 weeks
The distance from the base of the pocket to cemento-enamel junction (millimeters) is measured using an UNC-15 probe.
3 secondary outcomes
Full mouth plaque score
Time frame: 24 weeks
Full mouth bleeding score
Time frame: 24 weeks
Mean defect depth
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 21303402Cortellini 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.
- Background: PubMed 8483088Cortellini 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.
- Background: PubMed 8483087Cortellini 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.
- Background: PubMed 11829385Camelo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified minimally invasive surgical technique, modified minimally invasive surgical technique plus emdogain and modified minimally invasive surgical technique plus emdogain and xenograft in people with Periodontal Diseases and Periodontal Bone Loss, run by Rungta College of Dental Sciences and Research at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07310732, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.