Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis

NCT ID: NCT04000854

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-19
• Study Completion Date: 2023-12-19

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.

Conditions

Regenerative Endodontics in Traumatized Immature Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Calcium hydroxide

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

Group Type: ACTIVE_COMPARATOR

Calcium hydroxide (Calacept)

Intervention Type: DRUG

Long-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors

Chlorhexidine

Root canal dressing with clorhexidine digluconate 2 % gel

Group Type: ACTIVE_COMPARATOR

Calcium hydroxide (Calacept)

Intervention Type: DRUG

Long-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Clorhexidine digluconate 2 % gel

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastman Dental Insitute and Hospital

OTHER

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Georgios Tsilingaridis

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios Tsilingaridis, pHd

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Eastmaninstitutet

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Georgios Tsilingaridis, PhD

Role: CONTACT

georgios.tsilingaridis@ki.se

0046-8-52488029

Alina Wikström, PhD-student

Role: CONTACT

alina.wikstrom@sll.se

Facility Contacts

Alina Wikström, PhD student

Role: primary

alina.wikstrom@sll.se

Georgios Tsilingaridis, pHD

Role: backup

georgios.tsilingaridis@ki.se

0046-8-52488029

Other Identifiers

Regenerative endo 181116

Identifier Type: -

Identifier Source: org_study_id