Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis

April 7, 2022 updated by: Georgios Tsilingaridis, Karolinska Institutet

Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis: A Prospective Randomized Multicenter Study

Endodontic management of traumatized immature permanent teeth with pulp necrosis is both a clinical challenge for the dental practitioners and a public health care problem. Even though there are feasible treatment procedures (such as apexification with calcium hydroxide and with Mineral Trioxide Aggregate (MTA), the long-term survival of these teeth is questionable because none of these techniques can provide continuation of root formation and thickening of the dentin walls. As a result, the immature tooth is weak and prone to fracture.

Recently, regenerative endodontic procedures have gained much attention as biologically based treatment alternative to the techniques described above, but the scientific evidence is insufficient. These procedures aim to remove necrotic and damaged tissues and replace those with healthy functioning pulp-dentin complex.

We plan to invite 120 patients to participate in this study. The inclusion criteria will be children between the ages of 7-19 years with traumatized permanent incisors with immature roots and open apices and pulp necrosis. Patients will be recruited from specialist clinics in Stockholm, Västerbotten and Norrbotten. The patients will be treated by specialists in endodontics and pediatric dentistry with regenerative endodontics. During a 5-year follow-up period the most important outcomes are continuous root development and healing of pulp necrosis. Severe traumatic dental injuries leading to severe complication that could result in early tooth loss can have a severe impact on oral health related quality of life. Therefore, regenerative endodontics can have beneficial effect treating these teeth.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Traumatized permanent incisors with immature roots and open apices
  • pulp necrosis and apical periodontitis (if present)
  • No history of received endodontic treatment of the particular tooth
  • Pulp space not needed for post or core restoration
  • Good compliance of patient and parents
  • Ages from 7-19 years and both genders

Exclusion Criteria:

  • Traumatized permanent incisors with mature roots with closed apices (< 1 mm)
  • Retreatment cases
  • Marginal periodontitis
  • Root fracture
  • Intraoperative factors such as: lack of bleeding from the periapical tissue, exudate in the root canal prior to revascularization
  • Allergy to medicaments used for the treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Calcium hydroxide
Root canal dressing with Ca(OH)2 (Calasept)
Drug: Calcium hydroxide (Calacept)
Long-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors
Other Names:
  • Clorhexidine digluconate 2 % gel
Active Comparator: Chlorhexidine
Root canal dressing with clorhexidine digluconate 2 % gel
Drug: Calcium hydroxide (Calacept)
Long-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors
Other Names:
  • Clorhexidine digluconate 2 % gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apical periodontitis
Time Frame: Change from baseline radiograph at 12 months
Presence of apical periodontitis on radiographs after intervention using PeriApicalIndex (PAI).(1) Normal periapical structure; (2) small changes in bone struc- ture; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; and (5) severe periodontitis with exacerbating features.
Change from baseline radiograph at 12 months
Root development
Time Frame: Change from baseline radiograph at 12 months
Continous root development after on radiographs after intervention
Change from baseline radiograph at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical symptoms
Time Frame: Change from baseline at 6 months
Presence of clinical symptoms such as sinus tract, swelling, mobility, sensitivity on palpation and percussion, bacterial load after treatment with different dressing materials, presence of crown discoloration.
Change from baseline at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Umeå University
Eastman Dental Insitute and Hospital

Investigators

  • Principal Investigator: Georgios Tsilingaridis, pHd, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Anticipated)

December 19, 2023

Study Completion (Anticipated)

December 19, 2023

Study Registration Dates

First Submitted

June 24, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Regenerative endo 181116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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