PeriodontitisNCT06058923
MIST Versus M-MIST for the Treatment of Intrabony Defects
A study testing M-MIST and MIST in people with Periodontitis and Intrabony Periodontal Defect, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Intrabony Periodontal Defect, Periodontitis, Chronic
- What is being tested?
- M-MIST and MIST
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Aug 2023to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, 13414903
About this study
Official title: Minimally Invasive Surgical Techniques of Single Versus Double-flap for the Treatment of Isolated Intrabony Defects: a Randomized Controlled Clinical Trial
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.
Read the detailed description
This is a clinical trial, a randomized controlled double-blind parallel-design study with a 12-month follow-up. Participants will be recruited from patients diagnosed with periodontitis (Stage III/IV, Grade A or B) based on inclusion and exclusion criteria at the Postgraduate Periodontics Clinic of the Dental College of Piracicaba in the State University of Campinas (FOP-UNICAMP). The sample size calculation was based on a previous study, resulting in 50 participants, with 25 in each group. Participants will be randomly assigned to two treatment groups: Control Group (double-flap minimally invasive surgery) and Test Group (single-flap minimally invasive surgery).
This study will include clinical, digital, radiographic and patient-related outcome measures parameters. Clinical parameters including plaque index, bleeding on probing, probing depth, gingival recession, clinical attachment level, and early healing index will be measured at baseline, 6 months, and 12 months. Digital parameters, including mean change in papillary volume (mmVP) and change in gingival margin (mGM), will be assessed through intraoral scanning at baseline and 12 months. Radiographic measurements (linear, angular, and subtraction) will be performed before surgery and 12 months after using specialized software. Patient perception of pain and analgesic consumption will be evaluated using the Visual Analogue Scale (VAS) at various time points post-surgery (1-14 days after surgical intervention).
The clinical protocol involves pre-surgical therapy, surgical therapy, and post-operative care. After recording all the parameters through periodontal evaluation, X-ray acquisition procedures and intraoral scanning, a full-mouth supra and subgingival scaling and root planing will be performed. Afterwards, the surgery will be performed, following the randomization. Patients will receive post-operative analgesics and instructions for oral hygiene modifications. Periodontal maintenance will occur at specific intervals after surgery (1 month after surgery, 2 months after surgery, 4 months after surgery, 7 months after surgery, 10 months after surgery and 12 months after surgery).
For the statistical analysis, descriptive statistics will be used, and normality will be tested. Comparisons will be made using Student's t-test, one-way ANOVA, or non-parametric tests if data do not follow a normal distribution. A significance level of 5% will be used for all analyses.
- Being tested
- M-MIST, MIST
- Medical subject headings
- Periodontitis, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-MISTProcedure or surgery
Also called Minimally invasive single flap technique
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.
MISTProcedure or surgery
Also called Minimally invasive double flap technique
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.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Surgical Technique (MIST) | Active comparator | Double flap minimally invasive surgery for the access of intrabony defects Receives: Procedure: MIST |
| Modified Minimally Invasive Surgical Technique (M-MIST) | Experimental | Single flap minimally invasive surgery for the access of intrabony defects Receives: Procedure: M-MIST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Reduction of Probing Depth
Measured: 6 months and 1 year
Secondary outcomes (2)
Clinical Attachment Level
Gain of the Clinical Attachment Level
Measured: 6 months and 1 year
Subtraction Radiography
Gain of bone level
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start10 Aug 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
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
- Randomized controlled double-blind parallel-design clinical trial with a longitudinal duration of 12 months per participant, involving surgical therapeutic intervention.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enilson Antonio Sallum, University of Campinas, Brazil
- Investigators
- Thais FM Paschoal, MsC, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058923
- Sponsor's protocol ID
- 69036023.5.0000.5418
- Status last verified
- Jan 2026
- First submitted
- 21 Sep 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgical Techniques of Single Versus Double-flap for the Treatment of Isolated Intrabony Defects: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06058923
- Acronym / sponsor ID
- 69036023.5.0000.5418
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 28 Sep 2023 (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 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.
Detailed description
This is a clinical trial, a randomized controlled double-blind parallel-design study with a 12-month follow-up. Participants will be recruited from patients diagnosed with periodontitis (Stage III/IV, Grade A or B) based on inclusion and exclusion criteria at the Postgraduate Periodontics Clinic of the Dental College of Piracicaba in the State University of Campinas (FOP-UNICAMP). The sample size calculation was based on a previous study, resulting in 50 participants, with 25 in each group. Participants will be randomly assigned to two treatment groups: Control Group (double-flap minimally invasive surgery) and Test Group (single-flap minimally invasive surgery).
This study will include clinical, digital, radiographic and patient-related outcome measures parameters. Clinical parameters including plaque index, bleeding on probing, probing depth, gingival recession, clinical attachment level, and early healing index will be measured at baseline, 6 months, and 12 months. Digital parameters, including mean change in papillary volume (mmVP) and change in gingival margin (mGM), will be assessed through intraoral scanning at baseline and 12 months. Radiographic measurements (linear, angular, and subtraction) will be performed before surgery and 12 months after using specialized software. Patient perception of pain and analgesic consumption will be evaluated using the Visual Analogue Scale (VAS) at various time points post-surgery (1-14 days after surgical intervention).
The clinical protocol involves pre-surgical therapy, surgical therapy, and post-operative care. After recording all the parameters through periodontal evaluation, X-ray acquisition procedures and intraoral scanning, a full-mouth supra and subgingival scaling and root planing will be performed. Afterwards, the surgery will be performed, following the randomization. Patients will receive post-operative analgesics and instructions for oral hygiene modifications. Periodontal maintenance will occur at specific intervals after surgery (1 month after surgery, 2 months after surgery, 4 months after surgery, 7 months after surgery, 10 months after surgery and 12 months after surgery).
For the statistical analysis, descriptive statistics will be used, and normality will be tested. Comparisons will be made using Student's t-test, one-way ANOVA, or non-parametric tests if data do not follow a normal distribution. A significance level of 5% will be used for all analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled double-blind parallel-design clinical trial with a longitudinal duration of 12 months per participant, involving surgical therapeutic intervention.
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Surgical Technique (MIST) | Active comparator | Procedure: MISTDouble flap minimally invasive surgery for the access of intrabony defects |
| Modified Minimally Invasive Surgical Technique (M-MIST) | Experimental | Procedure: M-MISTSingle flap minimally invasive surgery for the access of intrabony defects |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| M-MISTAlso: Minimally invasive single flap techniqueThis 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. | Procedure or surgery | Modified Minimally Invasive Surgical Technique (M-MIST) |
| MISTAlso: Minimally invasive double flap techniqueA 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. | Procedure or surgery | Minimally Invasive Surgical Technique (MIST) |
Primary outcome
Probing Depth
Time frame: 6 months and 1 year
Reduction of Probing Depth
2 secondary outcomes
Clinical Attachment Level
Time frame: 6 months and 1 year
Subtraction Radiography
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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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.
Thais FM Paschoal, MsC principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-MIST and MIST in people with Periodontitis and Intrabony Periodontal Defect, run by University of Campinas, Brazil at 1 site in Brazil.
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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
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 Depth (time frame: 6 months and 1 year). 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 23 Jan 2026.