Skip to main content
OpenTrials
Completed

NCT Number: NCT03562039

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University, Cairo, Manyal, Egypt

Loading trial locations.

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - systemically healthy patients
  • 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.
  • 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.

Treatment and study plan

M-MIST

Procedure

minimal invasive surgical technique without thorough removal of granulation tissue

Primary outcomes

  1. 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

  1. changes in pocket probing depth

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

    distance from the depth of the pocket to the gingival margin

  2. changes in gingival recession

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

    distance of the exposed root surface from the cemento-enamel junction to the gingival margin

  3. amount of bone fill

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

    difference in bone fill in standardized periapical radiograogh

  4. patient pain and discomfort

    Time frame: at day of the surgery then at 1 , 3 and 7 days post-surgery

    by giving the patient a questionnaire to fill

  5. patient satisfaction

    Time frame: 12 months post-surgery

    by giving the patient a questionnaire to fill

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2018
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.