Comparison of Two Dental Techniques Used to Treat Teeth Which Have Become Infected or Painful Following Trauma

NCT01817413 | Completed Phase 4

• 2 other identifiers: RD&I 3968, UoL000590Controlled Trials
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Children often damage their front teeth. In approximately 6% of cases, the nerve inside the affected tooth dies (becomes 'non-vital') and natural root development stops. In these cases, the tooth requires a root canal treatment in order to prevent problems such as pain and dental abscesses from arising. However, because the roots of these young teeth are not fully formed, they are weaker and prone to fracture. In addition, root canal treatment is difficult because a root canal filling cannot be placed in a tooth which is not yet fully formed, due to the fact that the root has an 'open' end. To enable root canal treatment to be carried out, a 'barrier' must be placed at the end of the 'open' root. This can be done using materials called Calcium Hydroxide or Mineral Trioxide Aggregate (MTA). These materials are placed inside the root and sealed into the tooth. However, although they help to provide a barrier, they do not help to strengthen the walls of the root. Treatment with these materials requires multiple visits to the dentist, over a period of up to 18 months. There is evidence to suggest that an alternative treatment involving 'revascularisation' (recovery of the blood supply to the tooth) and the use of a triple antibiotic paste allows 'natural' root growth to restart, and also strengthens the walls of the root. Treatment can often be carried out in just two visits. The aim of this study is to discover whether there is a difference between one of two methods of treating non-vital teeth with open ends. It is thought that there will be no significant differences seen between the results of the two techniques. Children with teeth that fall into this category and require root canal treatment will be given one of two treatments, both of which aim to treat infection, close the root end and to allow healing to take place. Teeth will receive one of the following methods of root treatment:

1. 1.Revascularisation (recovery of the natural blood supply to the tooth) following placement of an antibiotic paste into the tooth root. The aim of this treatment is to allow 'natural' root growth to restart. Root growth will allow the tooth to form at barrier at the end of the root. No root canal filling will then be necessary.
2. 2.Closure of the open root end by placement of an artificial barrier at the end of the root so that a root canal filling can then be placed. This will be done with a dental material called Mineral Trioxide Aggregate (MTA). Non-vital teeth with an open end are routinely treated in this way at Liverpool Dental Hospital.

Conditions

Apexification; Apexogenesis; Pulp Necrosis; MTA; Pulp Revascularisation; Periapical Periodontitis; Non-vital Immature Tooth

Keywords

Calcium hydroxide; Pulp regeneration; Regenerative endodontics; Pulp revitalisation; Triple antibiotic paste; Root canal therapy; Root end closure; Tooth root; Tooth apex; Dental trauma; Non-vital; Immature; Incisor; Periapical periodontitis; Dental pulp

Outcome Measures

Primary Outcomes (2)

• Evidence of periapical healing

  Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.

  12 months

• Presence of a satisfactory apical barrier

  Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.

  12 months

Secondary Outcomes (4)

• Patient satisfaction

  12 months

• Evidence of root development

  12 months

• A satisfactorily restored tooth

  12 months

• Absence of signs and symptoms of failure of treatment (pain, mobility, tenderness to percussion, pathology e.g.sinus or swelling)

  12 months

Study Arms (2)

Apexification with MTA

ACTIVE COMPARATOR

The control group will receive: Visit 1: root canal dressing with calcium hydroxide Visit 2: apexification with mineral trioxide aggregate (MTA), followed by obturation of the root canal with gutta percha. Treatment will be carried out over two visits, two weeks apart.

Procedure: Mineral trioxide aggregate

Pulp revascularisation

EXPERIMENTAL

The experimental group will receive: Visit 1: root canal dressing with triple antibiotic paste Visit 2: pulp revascularisation procedure Treatment will be carried out over two visits, two weeks apart.

Procedure: Revascularisation

Interventions

Mineral trioxide aggregate PROCEDURE

An apical barrier of mineral trioxide aggregate (MTA cement) will be placed in the tooth root at the open apex in order to achieve root end closure via an apexification technique

Also known as: MTA, MTA cement, Apexification

Apexification with MTA

Revascularisation PROCEDURE

Pulp revascularisation will be induced by instrumentation through the open apex so that a blood clot forms within the root canal in order to achieve root end closure via apexogenesis

Also known as: Regenerative endodontics, Pulp revitalisation, Apexogenesis

Pulp revascularisation

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between 7 and 25 years of age
• Have no significant medical history
• Cooperative in the dental chair
• Able to commit to the recall schedules prescribed by the study
• Have one or more traumatised non-vital permanent maxillary central incisors with incomplete root development

You may not qualify if:

• Have a medical history that may complicate treatment
• Have a medical history for which the study procedures may place the patient at increased risk
• Have a diagnosis of avulsion or severe intrusion following dental trauma
• Less than half formed
• Have anatomical complexity (such as dens invaginatus)
• Have horizontal or vertical root fractures present
• Have evidence of root resorption

Sponsors & Collaborators

• University of Liverpool: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

University of Liverpool

Liverpool, L3 5PS, United Kingdom

Location

Related Links

• Current Controlled Trials Registration

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis

Interventions

mineral trioxide aggregate; Pemetrexed; Apexification; Regenerative Endodontics

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Root Canal Therapy; Endodontics; Dentistry

Study Officials

• C C Youngson

  University of Liverpool

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer & Postgraduate Research Student

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 25, 2013
• Study Start: February 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

GB (1)