Condition category
Oral Health
Date applied
13/05/2019
Date assigned
16/05/2019
Last edited
16/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Our study aims to repair perforations (procedural accidents) that occur during treatment of the primary teeth, and teeth will be followed clinically and radiographically within 12 months and more than that if it is required. These teeth were usually extracted after perforation occurrence, subsequently later problems in the adjacent and opposite teeth will occur in some cases in spite of the presence of space maintainer (an appliance is applied to protect from distance losing after extraction in primary dentation), but this treatment will preserve the affected teeth functionally until normal exfoliation. We will use a biocompatible material called MTA which previously tested in the treatment of such these cases in permanent teeth and was successful at all follow-up periods. Iatrogenic furcal perforations occur during pulp treatment and may lead to loss of the affected teeth. Treatment may be significant when these teeth are strategically important. Numerous materials have been suggested to repair perforations in permanent and primary teeth, and Mineral Trioxide Aggregate has been the golden standard.

Who can participate?
The participants in this study should have a tooth that has a specific complication called furcal perforation which is a procedural accident that occurred during the treatment of primary teeth. The participants can be male or female and have a primary tooth with an indication of pulp treating that called pulpotomy subsequently they should be with ages ranged from 3 to 9 or 10 years at most

What does the study involve?
Eligible patients will have their teeth treated with MTA and will then be followed clinically and radiographically for 12 months and for more than that if the expected outcome "Internal resorption" has occurred.

What are the possible benefits and risks of participating?
This treatment will a child's teeth functionally, and protect them from later problems that may occur if it remains untreated. This treatment involves minimal risk but going without treatment will lead to loss of the affected teeth. Side effects from this study will usually go away soon after the affected teeth are extracted.

Where is the study run from?
Tishreen University, Syria.

When is the study starting and how long is it expected to run for?
July 2015 to February 2019.

Who is funding the study?
The National Institutes of Health Clinical Center.

Who is the main contact?
Dr Baraa Aldayri
baraa.aldayri89@gmail.com

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Dr Baraa Aldayri

ORCID ID

http://orcid.org/0000-0002-2661-3599

Contact details

Tishreen University
P.O.Box 2230
Lattakia
00963
Syria
(963-41) 42 22 00
baraa.aldayri89@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

3532

Study information

Scientific title

Internal resorption associated with iatrogenic-furcal perforation repaired with MTA in a pulpotomized primary molar tooth: 24-month follow-up

Acronym

IRPM

Study hypothesis

Internal resorption may not be always considered as a pathologic radiographic sign, especially when it does not associate with periodontal defect or injury of the successor.

Ethics approval

Approved 14/07/2015, the IRB of Tishreen University (info@tishreen.edu.sy; 0096341420291), ref: 3532.

Study design

Case Report

Primary study design

Observational

Secondary study design

Case series

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available.

Condition

Internal resorption that occurred after repairing pulpotomized primary molar with MTA.

Intervention

The patient was examined and asked about general conditions that may interfere with the treatment, and then we started intervention and repairing the furcal perforation in the pulpotomized primary molar that occurred with the undergraduate student. A radiographic image was taken as a baseline image for later follow-up.

A 7-aged boy had an iatrogenic furcal perforation in the right second mandibular primary molar during pulpotomy procedure by an undergraduate student at the dental clinic, then he was sent immediately to the department of pediatric dentistry in Tishreen university- Lattakia- Syria for management. Medical history was taken again, and the parents had been told about the following procedure and the written concept was taken. We ensured that rubber dam in the right place, then we used a copious saline solution to removing pulp debris and eliminating the bleeding to confirm the presence of perforation, and then we used round and fisher diamond burs (Horico, DIAMANT, Germany) sized 014 and 010 respectively, to removing residual roof of the pulp chamber and amputating the coronal pulp, with copious saline irrigating. We used a cotton pellet moistened with 2.5% Sodium Hypochlorite (SH) (Al-Fares, Damascus, Syria) for several minutes to obtaining disinfection and hemostasis, and then MTA (MTA Cem, NEXOBIO, Chungcheongbuk-do, Korea) mixed with sterile water on a clean glass pad by using a sterilized spatula until obtaining the appropriate pasty texture, and the material was transferred to the pulp chamber using an amalgam carrier and condensed with a squeezed- cotton pellet that was moistened with sterile water. Then tooth was immediately restored with Glass Ionomer Cement GIC (Cavitan Plus, SpofaDental, Markoca, Jicin, Czech) without moistened cotton pellet over MTA (using a moistened cotton pellet over MTA here leads to a soupy texture of the MTA because of the excess humidity which comes from the applied cotton pellet in addition to bleeding from the furcation area and canals orifices, subsequently setting will not happen). The tooth was prepared after one week for repairing with a stainless steel crown SSC (3M ESPE, St. Paul, USA).

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Clinical symptoms or sighns that may occur after this treatment are measured using clinical examination every three months until the eruption of the succedaneous tooth.

Secondary outcome measures

Radiographic signs that may occur after the treatment are measured using radiographic examination using periapical images every 6 months.

Overall trial start date

14/07/2015

Overall trial end date

20/02/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Teeth were treated with pulpotomy.
2. Mechanical perforations.
3. Teeth with sub-base material of ZOE (Zinc Oxide-Eugenol) that has been applied for one week at most.
4. Restorable teeth.
5. Aged 3-10 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

It may contian 15 patints at most

Participant exclusion criteria

1. Cariously perforated- teeth.
2. Teeth which pulpotomy was not the real treatment by asking parents, using the previous periapical image, and excess/uncontrolled bleeding from the canal orifices).
3. Unrestorable teeth.
4. No presence of rubber dam during pulpotomy procedure.
5. Saliva contamination during pulpotomy procedure.

Recruitment start date

20/10/2015

Recruitment end date

20/10/2018

Locations

Countries of recruitment

Syria

Trial participating centre

Tishreen University
Syria
Lattakia
00963
Syria

Sponsor information

Organisation

Tishreen University

Sponsor details

Syria
Lattakia
00963
Syria
0941450850
abdulnourallah@tishreen.edu.sy

Sponsor type

University/education

Website

www.tishreen.edu.sy

Funders

Funder type

Government

Funder name

NIH Clinical Center

Alternative name(s)

Clinical Center, National Institutes of Health Clinical Center

Funding Body Type

government organisation

Funding Body Subtype

Research institutes and centers

Location

United States of America

Results and Publications

Publication and dissemination plan

I have sent this article to a journal that cared about case reports.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

14/05/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/05/2019: Trial's existence confirmed by the Ethical Committee of Tishreen University.