Treatment of Periodontal Intraosseous Defects
Condition: Periodontal Pocket
MeSH terms: Periodontal Pocket
Study type: Interventional

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
    

Intervention name(s): Minimally invasive surgical technique
Intervention type(s): Procedure
Intervention description(s): 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.
Other intervention name(s): Conventional open flap debridement with papilla preservation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment