Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis

NCT04000854 | Unknown

• 1 other identifier: Regenerative endo 181116
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

Dental trauma; pulp necrosis; regenerative; endodontics

Outcome Measures

Primary Outcomes (2)

• Apical periodontitis

  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

  Continous root development after on radiographs after intervention

  Change from baseline radiograph at 12 months

Secondary Outcomes (1)

• Clinical symptoms

  Change from baseline at 6 months

Study Arms (2)

Calcium hydroxide

ACTIVE COMPARATOR

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

Drug: Calcium hydroxide (Calacept)

Chlorhexidine

ACTIVE COMPARATOR

Root canal dressing with clorhexidine digluconate 2 % gel

Drug: Calcium hydroxide (Calacept)

Interventions

Calcium hydroxide (Calacept) 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

Also known as: Clorhexidine digluconate 2 % gel

Calcium hydroxide; Chlorhexidine

Eligibility Criteria

• Age: 7 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Eastman Dental Insitute and Hospital: collaborator
• Umeå University: collaborator

Study Sites (1)

Eastmaninstitutet

Stockholm, 11324, Sweden

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Calcium Hydroxide; Gels

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Georgios Tsilingaridis, pHd

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Tsilingaridis, PhD

CONTACT

0046-8-52488029; georgios.tsilingaridis@ki.se

Alina Wikström, PhD-student

CONTACT

alina.wikstrom@sll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 27, 2019
• Study Start: February 19, 2019
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)