Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis

Karolinska Institute

Status: Unknown

Conditions: Regenerative Endodontics in Traumatized Immature Teeth

Treatments: Drug: Calcium hydroxide (Calacept)

Study type: Interventional

Funder types: Other

Identifiers

NCT04000854

Regenerative endo 181116

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 7 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Calcium hydroxide

Active Comparator group

Description:

Root canal dressing with Ca(OH)2 (Calasept)

Treatment:

Drug: Calcium hydroxide (Calacept)

Chlorhexidine

Active Comparator group

Description:

Root canal dressing with clorhexidine digluconate 2 % gel

Treatment:

Drug: Calcium hydroxide (Calacept)