Clinical trial NCT04000854: Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis
Official title: Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis: A Prospective Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regenerative Endodontics in Traumatized Immature Teeth
Keywords: Dental trauma
pulp necrosis
regenerative
endodontics
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Eastman Dental Insitute and Hospital
name: Umeå University
First posted: 2019-06-27
Enrollment: 180
Sex: ALL
Minimum age (years): 7
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Apical periodontitis
timeFrame: Change from baseline radiograph at 12 months
measure: Root development
timeFrame: Change from baseline radiograph at 12 months
Secondary outcomes:
measure: Clinical symptoms
timeFrame: Change from baseline at 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Eastmaninstitutet
Study officials:
affiliation: Karolinska Institutet
name: Georgios Tsilingaridis, pHd
role: PRINCIPAL_INVESTIGATOR
References: