Treatment of Periodontal Intraosseous Defects
Primary Purpose
Periodontal Pocket
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Minimally invasive surgical technique
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Pocket
Eligibility Criteria
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
Sites / Locations
- Iorio Research and Dental Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Minimally invasive surgical technique
Conventional open flap debridement with papilla preservation
Arm Description
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).
The intra-bony defects of control group were treated using a combination of conventional open flap debridement with papilla preservation (COFD+PP) and EMD.
Outcomes
Primary Outcome Measures
Clinical attachment level gain ( CAL gain)
Vertical measure from the cement enamel junction to the bottom of the defect.
Secondary Outcome Measures
Full Information
NCT ID
NCT04542746
First Posted
July 30, 2020
Last Updated
September 2, 2020
Sponsor
Iorio Research and Dental Practice
1. Study Identification
Unique Protocol Identification Number
NCT04542746
Brief Title
Treatment of Periodontal Intraosseous Defects
Official Title
The Role of Surgical Flap Design on the Healing of Intraosseous Defects Treated by Means Regenerative Therapy. Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
August 12, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iorio Research and Dental Practice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minimally invasive surgical technique
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional open flap debridement with papilla preservation
Arm Type
Active Comparator
Arm Description
The intra-bony defects of control group were treated using a combination of conventional open flap debridement with papilla preservation (COFD+PP) and EMD.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive surgical technique
Other Intervention Name(s)
Conventional open flap debridement with papilla preservation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical attachment level gain ( CAL gain)
Description
Vertical measure from the cement enamel junction to the bottom of the defect.
Time Frame
At 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Iorio Research and Dental Practice
City
Naples
ZIP/Postal Code
80038
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Treatment of Periodontal Intraosseous Defects
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