Comparison of the GTR Procedure Alone and in Combination With Immediate OTM
Condition: Intrabony Periodontal Defect
Study type: Interventional

Summary: 
      The aim is to evaluate in a prospective, randomized, controlled clinical study the healing of
      a GTR procedure, when it is combined with an immediate orthodontic tooth movement or used
      alone. Clinical, radiological and reentry (histological) evaluation of a regenerative
      surgical method (GTR + grafting material) with different postsurgical healing patterns in the
      treatment of wide, non-containing intrabony defects.
    

Detailed description: 
      There is limited histological data in literature on the behavior of xenogeneic graft
      materials in intrabony defects used in periodontal regenerative therapy followed by
      orthodontic tooth movement (OTM). This clinical study aims to clinically and histologically
      evaluate the healing response of the periodontal tissues and the healing pattern of a
      non-resorbable graft material, when they are exposed to orthodontic forces. Therefore teeth
      presenting non-contained intrabony defects in combination with pathologic tooth migration
      (PTM) are included in this prospective clinical study. Guided tissue regeneration (GTR) with
      the application of deproteinized bovine bone mineral (DBBM) and a resorbable collagen
      membrane is utilized to surgically treat the periodontal defects, which is followed by a
      random allocation of the patients into test or control group. Subject teeth undergo an early
      initiated orthodontic treatment after surgery or stay splinted without any tooth movement in
      the latter groups, respectively. Teeth in test group can be further divided into subgroups,
      depending if they are moved toward to the former defect (pressure site) or moved away from
      the defect (tension site). After 9 months of healing a reentry surgery is performed, when a
      biopsy core is removed with a microtrephine from the previous defect site. The sample is
      evaluated by means of histology supplemented with histomorphometry, which is the primary
      outcome variable. Periodontal clinical parameters measured at baseline and at 9 months serves
      for secondary outcomes. Several studies confirmed the success of graft materials in such
      comprehensive treatment approaches clinically, but we lack the human histologically proved
      data, whether DBBM bone substitute can be used safely when the tooth is exposed to OTM. Our
      main question is how orthodontic induced bone remodelling interferes with these graft
      particles, can they heal the same or even better compared to control sites. Tissue response
      might be different also in the case of the two test subgroups.
    

Intervention name(s): Guided tissue regeneration (GTR); Orthodontic tooth movement (OTM)
Intervention type(s): Procedure; Device
Intervention description(s): GTR is handled with the utilization of a coronally advanced flap, followed by a thorough debridement of the denudated root surface and the intrabony component. Regenerative materials are resorbable collagen membrane (BioGide, Geistlich Phara AG, Wolhusen, Switzerland) and deproteinized bovine bone mineral (BioOss, Geistlich Phara AG), finally surgery is finished with multilayer suturing technique.; An early initialization of the tooth movement with the help of a multibond fixed orthodontic device utilizing low level of continuous orthodontic forces.
Other intervention name(s): Regenerative surgery of an intrabony periodontal defect; Multibond fixed orthodontic appliance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients undergo GTR procedure, after they are randomly allocated either to test (with OTM) or control group (without OTM)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: guided tissue regeneration; orthodontic tooth movement; histology; bone remodeling; deproteinized bovine bone mineral