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| Name | Class |
|---|---|
| Eastman Dental Insitute and Hospital | OTHER |
| UmeĂĄ University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium hydroxide | Active Comparator | Root canal dressing with Ca(OH)2 (Calasept) |
|
| Chlorhexidine | Active Comparator | Root canal dressing with clorhexidine digluconate 2 % gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Tsilingaridis, PhD | Contact | 0046-8-52488029 | georgios.tsilingaridis@ki.se | |
| Alina Wikström, PhD-student | Contact | alina.wikstrom@sll.se |
| Name | Affiliation | Role |
|---|---|---|
| Georgios Tsilingaridis, pHd | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastmaninstitutet | Recruiting | Stockholm | 11324 | Sweden |
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D002126 | Calcium Hydroxide |
| D005782 | Gels |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
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|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |