Efficacy of PRF With M-MIST in the Treatment of Intrabony Defects
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      This study evaluates the efficacy of M-MIST with or without PRF in the treatment of intrabony
      defects.Taking into consideration of advantages of PRF and M-MIST it was hypothesised that
      this combination (PRF+M-MIST) would be more beneficial in achieving healing of intrabony
      defects. Furthermore the concomitant use of Platelet Rich Fibrin with M-MIST has not been
      previously attempted in periodontal practice.
    

Detailed description: 
      INTRODUCTION

      In the last two decades, some clinical investigators have focused their interest on the
      development of minimally invasive surgical approaches in periodontal surgery. Harrel & Rees
      proposed the minimally invasive surgery (MIS) with the aim to produce minimal wounds, minimal
      flap reflection and gentle hand ling of the soft and hard tissues in periodontal surgery.
      Cortellini & Tonetti tested the use of operative microscopes and microsurgical instruments to
      increase visual acuity and accuracy in the application of papilla preservation flaps in
      periodontal regeneration. The increased patient acceptance and decreased morbidity with
      minimally invasive surgery offers a promising therapeutic modality and may replace the need
      for more extensive surgical procedures. Recently, a new surgical approach, the ''minimally
      invasive surgical technique (MIST)'', has been proposed to treat isolated intrabony defects
      with periodontal regeneration. Results from a cohort study in isolated deep intrabony defects
      showed marked improvements in terms of clinical attachment level (CAL) gains and PD
      reduction. The background foundations for this technique are the concepts of the MIS, and the
      application of papilla preservation techniques with a microsurgical approach. The cited study
      also reported a very limited patient morbidity and a reduced length of the surgical procedure
      following application of the MIST. An enhancement of this technique, the modified minimally
      invasive surgical technique (M-MIST), has been recently designed to further reduce the
      surgical invasiveness, with three major objectives in mind: (1) minimize the interdental
      tissue tendency to collapse, (2) enhance the wound/soft tissue stability and (3) reduce
      patient morbidity.

      Periodontal researchers and clinicians, in an effort to develop effective regenerative
      therapies, have sought to understand key events involved in the regeneration of the
      periodontium. An increased knowledge of specific cellular response and function within the
      periodontium has led to the development of numerous treatment modalities exhibiting different
      degrees of success.

      Treatments including ''grafting'' with bone or bone substitutes, stimulation of cells with
      growth factors, hormones, or extracellular matrix proteins; cell occlusive barrier membranes
      for selective cell growth in periodontal defects; and modification of the tooth root surface
      have all been explored for their ability to predictably regenerate the periodontium. Although
      some treatments have yielded promising results, there remains a need for a treatment that
      leads to faster and more predictable regeneration of the periodontium.

      The development of bioactive surgical additives, which are being used to regulate the
      inflammation and increase the speed of healing process, is one of the great challenges in
      clinical research. In this sense, healing is a complex process, which involves cellular
      organization, chemical signals, and the extracellular matrix for tissue repair. The
      understanding of healing process is still incomplete, but it is well known that platelets
      play an important role in both hemostasis and wound healing processes.

      Platelets' regenerative potential was introduced in the 70's, when it was observed that they
      contain growth factors that are responsible for increase collagen production, cell mitosis,
      blood vessels growth, recruitment of other cells that migrate to the site of injury, and cell
      differentiation induction, among others.

      One of the latest innovations in oral surgery is the use of platelet concentrates for in vivo
      tissue engineering applications. Platelet concentrates are a concentrated suspension of
      growth factors found in platelets, which act as bioactive Platelet rich fibrin (PRF) was
      first used in 2001 by Choukroun et al., specifically in oral and maxillofacial surgery, and
      is currently considered as a new generation of platelet concentrate. It consists of a matrix
      of autologous fibrin and has several advantages over Platelet rich plasma (PRP), including
      easier preparation and not requiring chemical manipulation of the blood, which makes it
      strictly an autologous preparation.

      PRF consists of an autologous leukocyte-platelet-rich fibrin matrix, composed of a tetra
      molecular structure, with cytokines, platelets, cytokines, and stem cells within it, which
      acts as a biodegradable scaffold that favors the development of microvascularization and is
      able to guide epithelial cell migration to its surface. Also, PRF may serve as a vehicle in
      carrying cells involved in tissue regeneration and seems to have a sustained release of
      growth factors in a period between 1 and 4 weeks, stimulating the environment for wound
      healing in a significant amount of time. It has a complex architecture of strong fibrin
      matrix with favorable mechanical properties and is slowly remodeled, similar to blood clot .
      Some studies have demonstrated that PRF is a healing biomaterial with a great potential for
      bone and soft tissue regeneration, without inflammatory reactions and may be used alone or in
      combination with bone grafts, promoting hemostasis, bone growth, and maturation. This
      autologous matrix demonstrated in in vitro studies a great potential to increase cell
      attachment and a stimulation to proliferate and differentiate osteoblasts. Dohan et al.
      stated that PRF has immunological and antibacterial properties, may lead to leukocyte
      degranulation, and has some cytokines that may induce angiogenesis and pro/anti-inflammatory
      reactions.

      Taking into consideration of above mentioned advantages of PRF and M-MIST it was hypothesised
      that this combination (PRF+M-MIST) would be more beneficial in achieving healing of intrabony
      defects. Furthermore the concomitant use of Platelet Rich Fibrin with M-MIST has not been
      previously attempted in periodontal practice. Thus the aim of the study is to evaluate the
      efficacy of PRF along with M-MIST in the treatment of intrabony defects.

      MATERIAL AND METHOD

      This study will be conducted in Department of Periodontics and Oral Implantology , Post
      Graduate Institute Of Dental Sciences,(PGIDS) Rohtak, Haryana.

      STUDY POPULATION

      Patients will be recruited from regular outpatient department of the Department of
      Periodontics and Oral Implantology. Minimum total 36 patients will be included as per
      eligibility in this study.

      Prior informed consent will be taken from each patient after explaining the procedure in
      patient's language along with risk and benefits involved.

      METHODOLOGY

      Sample size and randomization

      A total number of 36 patients were selected and divided into 2 groups of 18 each

      All the eligible patients will be randomly assigned at the time of surgery into either of the
      two groups:

        -  Test group: Modified-Minimally Invasive Surgical Technique + Platelet Rich Fibrin

        -  Control group: Modified-Minimally Invasive Surgical Technique alone.

      Clinical parameters

      All the clinical parameters will be recorded at baseline, 3 months and 6 months post-surgery.

      Gingival status will be assessed using the Loe and Silness Gingival Index . Plaque status
      will be recorded using Silness and Loe Plaque Index. The clinical parameters will include
      relative clinical attachment level (CAL), probing pocket depth (PPD) and gingival recession
      will be recorded to the nearest millimetre (at the deepest location of the selected
      interproximal site) with the help of a UNC-15 probe (university of north carolina)at
      baseline, 3 months and 6 months post-surgery.

      All the parameters will be clinically assessed by a single examiner.

      Radiographic parameters

      Intra-oral periapical radiographs of the selected teeth will be taken using long cone
      paralleling technique at baseline, 3 months and 6 months post-surgery.

      All the radiographs will be assessed by the another investigator.

      The anatomical landmarks of the intrabony defect will be selected on the radiographs based on
      the criteria set by Schei et al., which include cementoenamel junction (CEJ), alveolar crest
      (AC) and base of the defect (BD). The radiographic parameters evaluated will be percentage
      bone fill (%BF) and the change in alveolar crest position (C-ACP).

      Surgical approach (M-MIST)

      All the surgical procedures will be performed using microsurgical instruments. The
      defect-associated papilla will be surgically approached with the M-MIST . The defect
      associated papilla will be surgically approached with modified papilla preservation technique
      at interdental sites. A thorough surgical debridement of the osseous defect will be performed
      using curettes from under the papilla, aided with surgical microscope. The defect will be
      debrided with mini curettes and the root will be carefully planed. Special care will be taken
      to reach all the parts of the exposed root surface and residual bony wall partly hidden by
      the non elevated lingual and papillary soft tissue. To allow instrumentation the buccal
      papillary flap will be slightly reflected carefully protected with a periosteal elevator and
      frequently irrigated with saline. Once the debridement is over, the vertical defect depth
      (from the bottom of the defect to the alveolar crest) and the number of bony walls present
      will be recorded. If the vertical defect depth is ≥3 mm, final subject eligibility will be
      confirmed. The required quantity of the PRF will be delivered into the osseous defect in test
      group.

      Post-surgical care

      Appropriate post-operative instructions will be given to the patients. Sutures will be
      removed 1 week following surgery.
    

Intervention name(s): Modified-Minimally Invasive Surgical Technique + PRF; Modified-Minimally Invasive Surgical Technique
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment