Comparison of Two Dental Techniques Used to Treat Teeth Which Have Become Infected or Painful Following Trauma
Condition: Apexification; Apexogenesis; Pulp Necrosis; MTA; Pulp Revascularisation; Periapical Periodontitis; Non-vital Immature Tooth
MeSH terms: Periodontitis; Dental Pulp Necrosis; Periapical Periodontitis; Necrosis
Study type: Interventional
Phase: Phase 4

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. 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. 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.
    

Detailed description: 
      Participants will be randomly allocated in to one of the above treatment groups. This means
      that neither the participants, nor the researchers, will be able to choose which group a
      participant will be allocated to.

      In both techniques, in order to learn about the bacteria involved in non-vital teeth, the
      investigators will take samples of the bacteria within the root canal.

      The outcomes of the study will provide us with further information about root growth, the
      bacteria involved in infection of non-vital teeth and the success of the different treatment
      methods that are available. This information will enable us to increase our understanding of
      the treatment of non-vital teeth with an open end and help us to explain our treatments to
      future patients.

      All children presenting to Liverpool University Dental Hospital aged between 7 and 25 years
      of age and who are medically well and cooperative to receive prolonged treatment in the
      dental chair are eligible to take part in the study if they have a damaged upper front adult
      tooth in which the nerve has died and the root is open ended. Unfortunately, if there is
      dental decay in the tooth or a fracture of the root then these teeth are not suitable for
      this study. In some cases following damage to a tooth, the root of the tooth starts to
      dissolve and unfortunately these teeth are also not suitable for this study.

      Suitable patients attend with their parent or carer for a consultation to the Paediatric
      Dentistry Clinic at Liverpool University Dental Hospital. Following this visit, if a suitable
      patient wishes to join our study the investigators will arrange two further visits during
      which the dental treatment will take place. Following completion of treatment, patients will
      be asked to return for four check ups over the next year so that the investigators can check
      that they are happy and that treatment has been successful.

      There are no risks or disadvantages to taking part in this study. However, if the tooth does
      not respond to treatment, or if symptoms of infection arise, then alternative treatment
      methods may be initiated as necessary.

      The study is being funded by the Royal Liverpool and Broadgreen University Hospitals NHS
      Trust and by the University of Liverpool.
    

Intervention name(s): Mineral trioxide aggregate; Revascularisation
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; 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
Other intervention name(s): MTA; MTA cement; Apexification; Regenerative endodontics; Pulp revitalisation; Apexogenesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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