Condition category
Oral Health
Date applied
31/01/2017
Date assigned
02/02/2017
Last edited
02/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A root canal is a dental procedure that treats infection inside the tooth and prevents bacteria from re-entering the tooth. A possible side effect of this treatment is a tooth perforation (hole) which means bacteria can enter the tooth as there is contact with tissue that surrounds and supports the teeth (periodontium) and the root system of the tooth. A perforation needs to be sealed as soon as possible in order to save the tooth. This is usually done with gutta-percha, which is a rubber-like material. However, other sealants can be used to see if they help repair the perforation, such as white MTA and Biodetine. These sealants are made from a calcium-silicate based material and may help periodontium tissue to repair itself. This study aims to investigate the response of periodontal tissue when white MTA and Biodentine are used to seal teeth over a three-month period.

Who can participate?
Adults needing a root canal and have two teeth that need to be pulled.

What does the study involve?
Participants undergo their scheduled root canal according to standard care. Participants are randomly allocated to one of two groups. Those in group one have one tooth repaired with MTA and one tooth repaired with according to the standard practice. Those in group two have one tooth repaired with Biodentine and one tooth repaired according to the standard practice. Three months after the treatment, teeth are pulled and implants are placed done to the standard level of care. Samples from the tooth are taken during the process and are analysed to see how well they did at repairing the tooth perforation and if the periodontal tissue repaired itself.

What are the possible benefits and risks of participating?
Participants may benefit from a discount on the treatment price. There is a possible risk that participants may experience mild pain after the treatment and it can delay their treatment process.

Where is the study run from?
Clinica Odontoiatrica Salzano & Tirone (Italy)

When is the study starting and how long is it expected to run for?
October 2014 to May 2016

Who is funding the study?
Clinica Odontoiatrica Salzano & Tirone (Italy)

Who is the main contact?
Dr Tirone Federico
federico.tirone@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Tirone Federico

ORCID ID

http://orcid.org/0000-0001-6276-4557

Contact details

Via Cascina Colombaro 37C
CUNEO
12100
Italy
+39 017 161 9210
federico.tirone@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Response of periodontium to MTA and Biodentine: a randomised controlled histological study on humans

Acronym

Study hypothesis

This study is aimed at investigating the response of periodontal tissues in contact with white MTA and Biodentine over a three-month period, in order to determine whether periodontal regeneration in contact with such materials is possible in humans.

Ethics approval

Ethics Committee of Cuneo’s Hospital, 17/12/2014, ref: 07/14

Study design

Single-centre single-blind randomised controlled histological study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Root perforation

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.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/10/2014

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6

Participant exclusion criteria

1. Clinically significant medical history
2. Treated with immunosuppressive therapy or immunocompromised
3. Undergoing radiotherapy in the head/neck area
4. Previously treated or under treatment with intravenous amino-bisphosphonates
5. Pregnant or breastfeeding
6. Refusing to be included in the research protocol

Recruitment start date

18/12/2014

Recruitment end date

02/01/2016

Locations

Countries of recruitment

Italy

Trial participating centre

Clinica Odontoiatrica Salzano Tirone
Via Cascina Colombaro 37c
Cuneo
12100
Italy

Sponsor information

Organisation

Clinica Odontoiatrica Salzano Tirone

Sponsor details

Via Cascina Colombaro 37c
Cuneo
12100
Italy

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Clinica Odontoiatrica Salzano Tirone

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planning publication in a high impact journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Tirone Federico, federico.tirone@gmail.com

Intention to publish date

30/01/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes