Regenerative Endodontics in Traumatized Immature Teeth Clinical Trial
Official title:
Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis: A Prospective Randomized Multicenter Study
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.
| Status | Recruiting |
| Enrollment | 180 |
| Est. completion date | December 19, 2023 |
| Est. primary completion date | December 19, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 7 Years to 19 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Eastmaninstitutet | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet | Eastman Dental Insitute and Hospital, Umeå University |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Root development | Continous root development after on radiographs after intervention | Change from baseline radiograph at 12 months | |
| Secondary | 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 |