An interventional study of Calcium hydroxide (Calacept) in Regenerative Endodontics in Traumatized Immature Teeth, sponsored by Karolinska Institutet. Status unknown at 1 site in Sweden. Open to participants aged 7 Years to 19 Years. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
154 studies on the registry are indexed under Dental Pulp Necrosis; 40 are open to participants now.
This study's planned enrollment of 180 is above the median of 45 across 144 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.
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Exclusion Criteria:
Root canal dressing with Ca(OH)2 (Calasept)
Drug: Calcium hydroxide (Calacept)
Root canal dressing with clorhexidine digluconate 2 % gel
Drug: 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
Also known as: Clorhexidine digluconate 2 % gel
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.
Time frame: Change from baseline radiograph at 12 months
Root development
Continous root development after on radiographs after intervention
Time frame: Change from baseline radiograph at 12 months
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.
Time frame: Change from baseline at 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcium Hydroxide