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Clinical Trials/NCT03562039
NCT03562039
Completed
Not Applicable

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.

Cairo University1 site in 1 country16 target enrollmentApril 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery
Sponsor
Cairo University
Enrollment
16
Locations
1
Primary Endpoint
changes in clinical attachment level
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

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?

Registry
clinicaltrials.gov
Start Date
April 15, 2018
End Date
April 3, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Ibrahim

principle investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • - systemically healthy patients
  • Age range from 25 -
  • 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.
  • Perform and maintain good oral hygiene.
  • Able to come for the follow up appointment's needed

Exclusion Criteria

  • - Smokers.
  • Pregnant patients.
  • patients with poor oral hygiene.
  • Multirooted teeth with furcation involvement.

Outcomes

Primary Outcomes

changes in clinical attachment level

Time Frame: at baseline then 6, 9 and 12 months

It is the distance from the cement-enamel junction to the depth of the pocket.

Secondary Outcomes

  • patient satisfaction(12 months post-surgery)
  • amount of bone fill(at baseline then at 6, 9 and 12 months)
  • patient pain and discomfort(at day of the surgery then at 1 , 3 and 7 days post-surgery)
  • changes in pocket probing depth(at baseline then at 6, 9 and 12 months)
  • changes in gingival recession(at baseline then at 6, 9 and 12 months)

Study Sites (1)

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