Minimally-invasive non-surgical and surgical periodontitis treatment.

• Research type

  Research Study

• Full title

  Clinical and radiographic changes in intrabony defects following non-surgical vs. surgical minimally-invasive periodontal therapy. A parallel group, single centre, examiner-blind, non-inferiority randomised controlled trial.

• IRAS ID

  249543

• Contact name

  Nikos Donos

• Contact email

  n.donos@qmul.ac.uk

• Sponsor organisation

  Queen Mary University

• Duration of Study in the UK

  2 years, 5 months, 30 days

• Research summary

  The use of minimally-invasive procedures has recently been advocated for the treatment of periodontitis, in order to minimise patient discomfort and maximise the healing potential. No study to our knowledge has tested the efficacy of minimally-invasive non-surgical therapy (MINST) compared with surgical intervention (M-MIST) for the treatment of intrabony defects.

  This is a parallel group, single centre, single blind randomised controlled trial (RCT) to compare the effect of a novel treatment (MINST) to a surgical protocol (M-MIST) in the healing of periodontal intrabony defects in 66 chronic periodontitis (CP) patients. The primary outcome is radiographic bone level changes in test (MIST) and controls (MINST) at 15 months after treatment. Secondary outcomes are changes in periodontal clinical measurements, gingival blood flow, microbiological and inflammatory parameters and patient-reported outcomes before and after treatment in both study groups.
  
  Sixty-six patients will be recruited from the weekly general Restorative and Periodontal Consultation new patient clinics at Barts & The London Dental Hospital. Patients will be part of the study for approximately 16 months. Potential patients will undergo a baseline visit upon confirmation of consent to take part in the study. All patients will then be randomised to one of the two interventions (M-MIST vs MINST). The MINST protocol includes a non-surgical approach only, while M-MIST includes standard non-surgical therapy followed by surgical access to the residual intrabony defect. Patients will then be reviewed at approximately 3, 6, 9, 12 and 15 months post-intervention. A subgroup of 20 patients will also undergo 3D extra-oral Geometric/Thermal image capture (GTI sub-study). These patients will also attend two extra visits between the baseline and treatments' visits and two extra visits between the 3 and 6 months follow up visits. A full periodontal clinical and radiographic assessment will be carried out at the last visit for all patients. This study will shed light into preferable treatment options for intrabony defects and will clarify factors associated with healing. If results between MINST and surgical therapy are comparable, MINST might be considered a valid non-surgical treatment alternative for intrabony defect

• REC name

  London - Camden & Kings Cross Research Ethics Committee

• REC reference

  18/LO/1956

• Date of REC Opinion

  29 Nov 2018

• REC opinion

  Favourable Opinion