PeriodontitisNCT05225142
10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures
A study testing Modified minimally invasive surgery, Modified minimally invasive surgery with enamel matrix derivative and Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft in people with Periodontitis, run by The European Research Group on Periodontology (ERGOPerio) at 1 site in Italy.
Trial summary
Evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Modified minimally invasive surgery, Modified minimally invasive surgery with enamel matrix derivative and Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2007to 31 Mar 2020
- 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
- Subjects with periodontitis
- Presence of one intrabony defect not extending into furcation
- Good general health
- Adequate plaque control
Who cannot join
- Furcation involvement in the experimental tooth
- Inadequate control of periodontitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Minimally Invasive Surgical Technique in Human Intrabony Defects With or Without Regenerative Materials 10-year Follow-up of a Randomized Clinical Trial: Tooth Retention, Periodontitis Recurrence and Costs
Evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects.
Read the detailed description
This 10-year follow-up of a randomized controlled clinical trial (Cortellini \& Tonetti 2011) compares three treatment modalities in deep intrabony defects: i) a control group was treated with modified minimally invasive surgical technique alone (M-MIST, N=15); ii) a second group was treated with M-MIST combined with enamel matrix derivative (M-MIST EMD, N=15, Straumann, Switzerland); iii) a third group was treated with M-MIST+EMD plus Bone Mineral Derived Xenograph (M-MIST+EMD+BMDX, N=15, Geistlich, Switzerland) . The design of the original trial has been reported along with the one-year results and the details of randomization and allocation concealment (Cortellini \& Tonetti 2011). Clinical outcomes of the three groups were longitudinally followed for 10 years. The 10-year follow-up was approved by the local ethical committee for clinical research of the Health Service of Tuscany (University Hospital of Firenze protocol ATRO2019, registration n° 15106_oss). All patients gave informed consent to participate into the clinical trial.
- Conditions
- Periodontitis
- Being tested
- Modified minimally invasive surgery, Modified minimally invasive surgery with enamel matrix derivative, Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified minimally invasive surgeryProcedure or surgery
Also called M-MIST
Surgical intervention alone
Modified minimally invasive surgery with enamel matrix derivativeProcedure or surgery
Also called M-MIST with EMD
Surgical intervention with local application of regenerative biomaterial
Modified minimally invasive surgery with enamel matrix derivative and bone replacement graftProcedure or surgery
Also called M-MIST EMD+BRG
Surgical intervention with local application of regenerative biomaterial and bone replacement graft
| Study group | Role | What they receive |
|---|---|---|
| Modified minimally invasive surgery alone | Experimental | Modified minimally invasive surgery alone for access and debridement of intrabony defect. This approach maximises wound stability. No application of regenerative biomaterial. Receives: Procedure: Modified minimally invasive surgery |
| Modified minimally invasive surgery with enamel matrix derivative | Active comparator | Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative (regenerative biomaterial) Receives: Procedure: Modified minimally invasive surgery; Procedure: Modified minimally invasive surgery with enamel matrix derivative |
| Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft | Active comparator | Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative and bone replacement graft (regenerative biomaterial) Receives: Procedure: Modified minimally invasive surgery; Procedure: Modified minimally invasive surgery with enamel matrix derivative; Procedure: Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level changes
Periodontal probing to the nearest millimetre
Measured: 10 years
Secondary outcomes (5)
Probing pocket depts
Periodontal maintainability
Measured: 10 years
Tooth survival
Survival of treated teeth - Kaplan Mayer
Measured: 10 years
Complication-free survival
Survival until first episode of recurrence requiring re-treatment
Measured: 10 years
Cost of recurrence
Total cost of managing the regretted teeth including treatment of recurrence
Measured: 10 years
Radiographic bone level
Changes in level of bone supporting the tooth
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Jan 2007
- Primary completion31 Dec 2009
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Model description
- Long term follow up of RCT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierpaolo Cortellini, MD, Principal investigator, ATRO - ERGOPERIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225142
- Sponsor's protocol ID
- ATRO M-MIST
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Minimally Invasive Surgical Technique in Human Intrabony Defects With or Without Regenerative Materials 10-year Follow-up of a Randomized Clinical Trial: Tooth Retention, Periodontitis Recurrence and Costs
- ClinicalTrials.gov ID
- NCT05225142
- Acronym / sponsor ID
- ATRO M-MIST
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)Research network
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 4 Feb 2022 (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.
Evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects.
Detailed description
This 10-year follow-up of a randomized controlled clinical trial (Cortellini \& Tonetti 2011) compares three treatment modalities in deep intrabony defects: i) a control group was treated with modified minimally invasive surgical technique alone (M-MIST, N=15); ii) a second group was treated with M-MIST combined with enamel matrix derivative (M-MIST EMD, N=15, Straumann, Switzerland); iii) a third group was treated with M-MIST+EMD plus Bone Mineral Derived Xenograph (M-MIST+EMD+BMDX, N=15, Geistlich, Switzerland) . The design of the original trial has been reported along with the one-year results and the details of randomization and allocation concealment (Cortellini \& Tonetti 2011). Clinical outcomes of the three groups were longitudinally followed for 10 years. The 10-year follow-up was approved by the local ethical committee for clinical research of the Health Service of Tuscany (University Hospital of Firenze protocol ATRO2019, registration n° 15106_oss). All patients gave informed consent to participate into the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Long term follow up of RCT
| Arm | Type | Receives |
|---|---|---|
| Modified minimally invasive surgery alone | Experimental | Procedure: Modified minimally invasive surgeryModified minimally invasive surgery alone for access and debridement of intrabony defect. This approach maximises wound stability. No application of regenerative biomaterial. |
| Modified minimally invasive surgery with enamel matrix derivative | Active comparator | Procedure: Modified minimally invasive surgery, Procedure: Modified minimally invasive surgery with enamel matrix derivativeModified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative (regenerative biomaterial) |
| Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft | Active comparator | Procedure: Modified minimally invasive surgery, Procedure: Modified minimally invasive surgery with enamel matrix derivative, Procedure: Modified minimally invasive surgery with enamel matrix derivative and bone replacement graftModified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative and bone replacement graft (regenerative biomaterial) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with periodontitis
- Presence of one intrabony defect not extending into furcation
- Good general health
- Adequate plaque control
Key exclusion criteria (2 listed)
- Furcation involvement in the experimental tooth
- Inadequate control of periodontitis
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 surgeryAlso: M-MISTSurgical intervention alone | Procedure or surgery | Modified minimally invasive surgery alone, Modified minimally invasive surgery with enamel matrix derivative, Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft |
| Modified minimally invasive surgery with enamel matrix derivativeAlso: M-MIST with EMDSurgical intervention with local application of regenerative biomaterial | Procedure or surgery | Modified minimally invasive surgery with enamel matrix derivative, Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft |
| Modified minimally invasive surgery with enamel matrix derivative and bone replacement graftAlso: M-MIST EMD+BRGSurgical intervention with local application of regenerative biomaterial and bone replacement graft | Procedure or surgery | Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft |
Primary outcome
Clinical attachment level changes
Time frame: 10 years
Periodontal probing to the nearest millimetre
5 secondary outcomes
Probing pocket depts
Time frame: 10 years
Tooth survival
Time frame: 10 years
Complication-free survival
Time frame: 10 years
Cost of recurrence
Time frame: 10 years
Radiographic bone level
Time frame: 10 years
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 4 Feb 2022.
- Individual participant dataSharing planned: No. No plan to share data
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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.
Pierpaolo Cortellini, MD principal investigator
ATRO - ERGOPERIO
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 surgery, Modified minimally invasive surgery with enamel matrix derivative and Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft in people with Periodontitis, run by The European Research Group on Periodontology (ERGOPerio) at 1 site in Italy.
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 4 inclusion and 2 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 4 Feb 2022. 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 Italy. 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. 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?
Clinical attachment level changes (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2022.