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Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis

NCT04000854 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-04-08

No results posted yet for this study

Summary

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.

Conditions

  • Regenerative Endodontics in Traumatized Immature Teeth

Interventions

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

Sponsors & Collaborators

  • Eastman Dental Insitute and Hospital

    collaborator OTHER

  • Umeå University

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Georgios Tsilingaridis, pHd · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2023-12-19
Completion
2023-12-19

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04000854 on ClinicalTrials.gov