Repairing experimental tooth root perforations with different commercial materials

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Participants are randomly assigned to one of two groups, either the MTA group of the Biodentine group. Two teeth that are scheduled for extraction are randomly assigned to either being designated the test tooth or the control tooth. Randomisation of treatment groups is generated from a computer program, in order to choose the treatment with either MTA or Biodentine. Only one investigator is aware of the sequence and is allowed to access the file. The randomised codes are put into sequentially sealed envelopes which are opened by the investigator performing the endodontic treatment after preparing the perforation, so as to determine the treatment assigned to each tooth. In order to establish whether the test tooth had to be the right or the left one, a further couple of envelopes containing the words “test” and “control” was prepared for each patient and then the envelopes were sealed. At this point, an independent assistant is asked to write “right” and “left” on the envelopes. Participants undergo a root canal (endodontic treatment) under local anesthesia. The root canals are done according to the standard care of practice until the perforation part of the procedure. At this point of the procedure, the envelopes are opened and the perforation was done according to the randomization process. Group 1 (MTA): The test tooth perforation is repaired with MTA and control tooth perforation is filled with root canal sealer and gutta‐percha during the endodontic treatment. Group 2 (Biodentine): The test tooth perforation is repaired with Biodentine and control tooth perforation is filled with root canal sealer and gutta‐percha during the endodontic treatment. Three months after the root canal, the teeth are extracted and implants are placed. This is done according to the standard care of practice. Biopsy samples are taken from the tooth during the extraction process and stored in a glycolmethacrylate resin. These are then analysed under a microscope in a laboratory. CONDITION: Root perforation ; Oral Health ; Root perforation PRIMARY OUTCOME: 1. Formation of mineralised tissue over the filling material material is measured using the histological analysis at 3 months ; 2. PDL fibres orientation is evaluated using thehistological analysis under polarised light at 3 months; 3. Presence of inflammatory cell infiltrate, classified as follows: null, when there are no inflammatory cells; mild, when there are few inflammatory cells; moderate, when inflammatory cells do not replace the normal tissue; severe, when inflammatory cells replace the normal tissue is measured using the histological analysis at 3 months SECONDARY OUTCOME: 1. The presence or absence of a fibrous capsule formation is measured using histological analysis at 3 months; 2. Root resorption is measured using histological analysis at 3 months; 3. Ankylosis is measured using histological analysis at 3 months; 4. Epithelial proliferation is measured using histological analysis at 3 months; INCLUSION CRITERIA: 1. Adults aged 18‐60 years old 2. Healthy patients 3. Needing all‐on‐4 rehabilitation 4. Having at least two vital and periodontally healthy monoradicular teeth scheduled for extraction
Epistemonikos ID: 7485a001e0589958d7e366688d80eb9c693c7603
First added on: Aug 23, 2024