Periodontal PocketNCT04542746
Treatment of Periodontal Intraosseous Defects
A study testing Minimally invasive surgical technique in people with Periodontal Pocket, run by Iorio Research and Dental Practice at 1 site in Italy.
Trial summary
The aim of the present study was to evaluate the impact of surgical flap design on the healing of intrabony defects treated by means periodontal regeneration. Forty patients were enrolled and allocated random in two groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- Minimally invasive surgical technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jul 2017to 18 Dec 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients suffering from chronic periodontitis;
- Male and female ;
- Age 18 years old;
- Presence of intra-bony defects (contained and non-contained defects) in either the maxilla or the mandible with a PD ≥ 6 mm.
- II and III wall Intra-bony defects with an intra-bony component range from 3 mm to 6 mm for both groups;
- Intra-bony defect located only at one aspect ( mesial or distal)
Who cannot join
- • Patients with systemic disease;
- Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery;
- Pregnant or lactating;
- Tobacco smokers;
- Patients with FMPS and FMBS 25 % after completion of non surgical periodontal therapy (recorded at six sites per tooth);
- Furcations;
Show all 9Show fewer
- Third molars
- Teeth with circumferencial defects
- I-wall intra-bony defects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Surgical Flap Design on the Healing of Intraosseous Defects Treated by Means Regenerative Therapy. Randomized Controlled Clinical Trial.
The aim of the present study was to evaluate the impact of surgical flap design on the healing of intrabony defects treated by means periodontal regeneration. Forty patients were enrolled and allocated random in two groups. Patients of test group received a minimally invasive surgical flap , while patients of control group received a conventional access flap. In both group the intrabony were treated by means the same periodontal regeneration procedure (i.e application of enamel matrix derivative). Periodontal parameters were recoded at baseline and after 12-months observation time.
Read the detailed description
This study was designed as multicenter randomized control clinical trial. The present trial was conduced according to CONSORT statement for improving the quality of reports of parallel-group randomized trials .
The intra-bony defects of subjects allocated in test group were treated with a combination of minimally invasive surgical technique (MIST) and enamel matrix derivative(EMD), while the intra-bony defects of control group were treated using a combination of conventional open flap debridement with papilla preservation (COFD+PP) and EMD.
Primary outcome
The primary outcome was based on Clinical attachment level gain( CAL gain)
Null hypothesis
Statistically significant different in terms of CAL gain will be recorded between test and control procedures.
Sample Size Calculation
The investigators are planning a study of a continuous response variable from independent control and experimental subjects with 1 control per experimental subject. In a previous study the response within each subject group was normally distributed with standard deviation 0,92. If the true difference in the experimental and control means is 0,97, we will need to study 20 experimental subjects and 20 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0,8. The Type I error probability associated with this test of this null hypothesis is 0,05. Twenty-six patients were enrolled in the study and allocated in test or control group. In each patients 1 intra-bony defect was considered.
Randomization
The patients were randomly assigned to one of the two experimental procedures. The allocation was carried out using a commercially available computer software package. Treatment allocation was performed at time of surgery by opening an envelope containing the information test (i.e.EMD + MIST) or control (i.e.EMD + COFD+PP) procedure, respectively.
Inclusion Criteria
- Patients suffering from chronic periodontitis;
- Male and female ;
- Age 18 years old;
- Presence of intra-bony defects (contained and non-contained defects) in either the maxilla or the mandible with a PD ≥ 6 mm.
- II and III wall Intra-bony defects with an intra-bony component range from 3 mm to 6 mm for both groups;
- Intra-bony defect located only at one aspect ( mesial or distal)
Exclusion Criteria
- Patients with systemic disease;
- Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery;
- Pregnant or lactating;
- Tobacco smokers;
- Patients with FMPS and FMBS 25 % after completion of non surgical periodontal therapy (recorded at six sites per tooth);
- Furcations;
- Third molars
- Teeth with circumferencial defects
- I-wall intra-bony defects
- Conditions
- Periodontal Pocket
- Being tested
- Minimally invasive surgical technique
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgical techniqueProcedure or surgery
Also called Conventional open flap debridement with papilla preservation
After local anesthesia , for the sites of test group , a minimally invasive surgical technique (MIST) will be performed. The defects associated inter-dental papilla will be surgically approached with a diagonal incision following the pattern of the simplified papilla preservation flap. Flap elevation was to the buccal and oral aspect in the interdental space, An enamel matrix derivative (EMD) was applied into the defect.f A primary closure of the interdental papillae will be achieved using a 5-0 monofilament non resorbable suturing material.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive surgical technique | Experimental | The intra-bony defects of subjects allocated in test group were treated with a combination of minimally invasive surgical technique (MIST) and enamel matrix derivative( EMD). Receives: Procedure: Minimally invasive surgical technique |
| Conventional open flap debridement with papilla preservation | Active comparator | The intra-bony defects of control group were treated using a combination of conventional open flap debridement with papilla preservation (COFD+PP) and EMD. Receives: Procedure: Minimally invasive surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level gain ( CAL gain)
Vertical measure from the cement enamel junction to the bottom of the defect.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start28 Jul 2017
- Primary completion12 Aug 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iorio Research and Dental Practice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Iorio-Siciliano, Iorio Research and Dental Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542746
- Sponsor's protocol ID
- 0012240
- Status last verified
- Sep 2020
- First submitted
- 30 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Surgical Flap Design on the Healing of Intraosseous Defects Treated by Means Regenerative Therapy. Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04542746
- Acronym / sponsor ID
- 0012240
- Conditions
- Periodontal Pocket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Iorio Research and Dental PracticeUniversity, hospital or other
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 12 Aug 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 9 Sep 2020 (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.
The aim of the present study was to evaluate the impact of surgical flap design on the healing of intrabony defects treated by means periodontal regeneration. Forty patients were enrolled and allocated random in two groups. Patients of test group received a minimally invasive surgical flap , while patients of control group received a conventional access flap. In both group the intrabony were treated by means the same periodontal regeneration procedure (i.e application of enamel matrix derivative). Periodontal parameters were recoded at baseline and after 12-months observation time.
Detailed description
This study was designed as multicenter randomized control clinical trial. The present trial was conduced according to CONSORT statement for improving the quality of reports of parallel-group randomized trials .
The intra-bony defects of subjects allocated in test group were treated with a combination of minimally invasive surgical technique (MIST) and enamel matrix derivative(EMD), while the intra-bony defects of control group were treated using a combination of conventional open flap debridement with papilla preservation (COFD+PP) and EMD.
Primary outcome
The primary outcome was based on Clinical attachment level gain( CAL gain)
Null hypothesis
Statistically significant different in terms of CAL gain will be recorded between test and control procedures.
Sample Size Calculation
The investigators are planning a study of a continuous response variable from independent control and experimental subjects with 1 control per experimental subject. In a previous study the response within each subject group was normally distributed with standard deviation 0,92. If the true difference in the experimental and control means is 0,97, we will need to study 20 experimental subjects and 20 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0,8. The Type I error probability associated with this test of this null hypothesis is 0,05. Twenty-six patients were enrolled in the study and allocated in test or control group. In each patients 1 intra-bony defect was considered.
Randomization
The patients were randomly assigned to one of the two experimental procedures. The allocation was carried out using a commercially available computer software package. Treatment allocation was performed at time of surgery by opening an envelope containing the information test (i.e.EMD + MIST) or control (i.e.EMD + COFD+PP) procedure, respectively.
Inclusion Criteria
- Patients suffering from chronic periodontitis;
- Male and female ;
- Age 18 years old;
- Presence of intra-bony defects (contained and non-contained defects) in either the maxilla or the mandible with a PD ≥ 6 mm.
- II and III wall Intra-bony defects with an intra-bony component range from 3 mm to 6 mm for both groups;
- Intra-bony defect located only at one aspect ( mesial or distal)
Exclusion Criteria
- Patients with systemic disease;
- Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery;
- Pregnant or lactating;
- Tobacco smokers;
- Patients with FMPS and FMBS 25 % after completion of non surgical periodontal therapy (recorded at six sites per tooth);
- Furcations;
- Third molars
- Teeth with circumferencial defects
- I-wall intra-bony defects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive surgical technique | Experimental | Procedure: Minimally invasive surgical techniqueThe intra-bony defects of subjects allocated in test group were treated with a combination of minimally invasive surgical technique (MIST) and enamel matrix derivative( EMD). |
| Conventional open flap debridement with papilla preservation | Active comparator | Procedure: Minimally invasive surgical techniqueThe intra-bony defects of control group were treated using a combination of conventional open flap debridement with papilla preservation (COFD+PP) and EMD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Patients suffering from chronic periodontitis;
Key exclusion criteria (9 listed)
- • Patients with systemic disease;
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 |
|---|---|---|
| Minimally invasive surgical techniqueAlso: Conventional open flap debridement with papilla preservationAfter local anesthesia , for the sites of test group , a minimally invasive surgical technique (MIST) will be performed. The defects associated inter-dental papilla will be surgically approached with a diagonal incision following the pattern of the simplified papilla preservation flap. Flap elevation was to the buccal and oral aspect in the interdental space, An enamel matrix derivative (EMD) was applied into the defect.f A primary closure of the interdental papillae will be achieved using a 5-0 monofilament non resorbable suturing material. | Procedure or surgery | Conventional open flap debridement with papilla preservation, Minimally invasive surgical technique |
Primary outcome
Clinical attachment level gain ( CAL gain)
Time frame: At 12 months
Vertical measure from the cement enamel junction to the bottom of the defect.
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 9 Sep 2020.
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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 Minimally invasive surgical technique in people with Periodontal Pocket, run by Iorio Research and Dental Practice 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 6 inclusion and 9 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 9 Sep 2020. 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 gain ( CAL gain) (time frame: At 12 months). 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 9 Sep 2020.