Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis

Study Overview
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Brief Summary
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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.

Official Title
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Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis: A Prospective Randomized Multicenter Study

Conditions
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Regenerative Endodontics in Traumatized Immature Teeth

Intervention / Treatment
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* Drug: Calcium hydroxide (Calacept)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium hydroxide<br>Root canal dressing with Ca(OH)2 (Calasept) | Drug: Calcium hydroxide (Calacept)<br>* Long-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors<br>* Other names: Clorhexidine digluconate 2 % gel;|
| Active Comparator: Chlorhexidine<br>Root canal dressing with clorhexidine digluconate 2 % gel | Drug: Calcium hydroxide (Calacept)<br>* Long-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors<br>* Other names: Clorhexidine digluconate 2 % gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptoms | Presence of clinical symptoms such as sinus tract, swelling, mobility, sensitivity on palpation and percussion, bacterial load after treatment with different dressing materials, presence of crown discoloration. | Change from baseline at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental trauma, pulp necrosis, regenerative, endodontics