Evaluation of Healing of Intra-bony Defects in Modified Minimal Invasive Surgical Technique

Study Overview
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Brief Summary
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This study is aiming to compare the clinical and radiographic outcomes after complete versus incomplete removal of granulation tissue during modified minimally invasive surgical technique for management of periodontal intrabony defects in patients with chronic periodontitis.

Detailed Description
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Periodontal surgery has been expanding in the world of dentistry throughout the past years, as new techniques are emerging to treat the different and complex periodontal disorders. Surgical procedures in dentistry have undergone major changes to minimize invasiveness. In addition, novel instruments and materials have been made to suit the evolution of the surgical procedures (Cortellini. 2012). Teeth with deep pockets associated with deep intra-bony defects are a clinical challenge for periodontists, where periodontal regeneration has been proven to be effective in managing the treatment of one-, two-, and three-wall intra-bony defects (Needleman and Tucker 2012;Needleman. 2015). Harrel and Rees (1995) were the first to introduce the term minimally invasive surgery (MIS). MIS is used to describe the use of smaller and more precise surgical procedures that are possible by using of magnifying instruments, such as operating microscopes and microsurgical instruments and materials (Cortellini. 2012). The rationale for the development of minimally invasive surgical technique (MIST) includes: reduction of trauma during the surgery, increase in flap and wound stability, improvement of wound primary closure, reduction of surgical time, and minimization of intra-operative and post-operative patient discomfort (Cortellini. 2007). With the use of MIST, Cortellini and Tonneti (2009) confirmed blood clot protection with the aspects of wound and blood clot stability and primary wound closure. An enhancement of MIST, the modified minimally invasive surgical technique (M-MIST), has been introduced by Cortellini in 2009 to further reduce the surgical invasiveness, with three major objectives in mind: (1) minimize the interdental tissue tendency to collapse providing space provision for regeneration, (2) enhance the wound/soft tissue stability and (3) reduce patient morbidity. Some authors evaluated the use of various regenerative material in MIST and M-MIST e.g. Enamel matrix derivative (Cortellini 2007) PDGF-bb (Cosyn et al. 2012) and collagen enriched bovine derived xeno-graft (Mishra et al., 2013). Cortellini (2011) also, noted that the use of regenerative material is not necessary with M-MIST. Hung et al, (2012) reported that granulation tissue could contain progenitor stem cells which are very important components needed for periodontal tissue regeneration. Moreover, Park et al. (2011) assumed that the inflamed granulation tissue could be used to regenerate lost tissues in the same individual in other defective sites according to its regenerative potential. All the previous data raised an important question about the necessity to remove granulation tissues in periodontal regenerative techniques: Is complete removal of granulation tissue in M-MIST is mandate for treating isolated intra-bony defects for better healing?

Official Title
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Clinical and Radiographic Evaluation of Intra Bony Defects Following Complete Versus Incomplete Removal of Granulation Tissue in Modified Minimally Invasive Surgical Technique (M-MIST). A Randomized Controlled Clinical Trial.

Conditions
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Periodontal Bone Loss

Intervention / Treatment
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* Procedure: M-MIST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Medically free patients attending the outpatient clinic. Both sexes will be included. Age range from 25 - 55. Patients with moderate to advanced chronic periodontitis with pockets ≥ 5 mm 6-8 weeks after phase I (non-surgical) therapy. Vertical 2 or 3 walls Intra-bony defects ≥ 3mm. Perform and maintain good oral hygiene. Able to come for the follow up appointment's needed Exclusion Criteria: - Smokers. Pregnant patients. Uncooperative patients with poor oral hygiene. Multirooted teeth with furcation involvement.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M-MIST (group A)<br>M-MIST(incomplete granulation tissue removal) | Procedure: M-MIST<br>* minimal invasive surgical technique without thorough removal of granulation tissue<br>|
| Active Comparator: M-MIST (group B)<br>conventional M-MIST. | Procedure: M-MIST<br>* minimal invasive surgical technique without thorough removal of granulation tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in clinical attachment level | It is the distance from the cement-enamel junction to the depth of the pocket. | at baseline then 3 , 6 and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in pocket probing depth | distance from the depth of the pocket to the gingival margin | at baseline then at 3,6 and 9 months | 
| changes in gingival recession | distance of the exposed root surface from the cemento-enamel junction to the gingival margin | at baseline then at 3,6 and 9 months | 
| amount of bone fill | difference in bone fill in standardized periapical radiograogh | at baseline then at 6 and 9 months | 
| patient pain and discomfort | by giving the patient a questionnaire to fill | at day of the surgery then at 1 , 3 and 7 days post-surgery | 
| patient satisfaction | by giving the patient a questionnaire to fill | 9 months post-surgery |