Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis
Primary Purpose
Regenerative Endodontics in Traumatized Immature Teeth
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Calcium hydroxide (Calacept)
Sponsored by
About this trial
This is an interventional treatment trial for Regenerative Endodontics in Traumatized Immature Teeth focused on measuring Dental trauma, pulp necrosis, regenerative, endodontics
Eligibility Criteria
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
Sites / Locations
- EastmaninstitutetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Calcium hydroxide
Chlorhexidine
Arm Description
Root canal dressing with Ca(OH)2 (Calasept)
Root canal dressing with clorhexidine digluconate 2 % gel
Outcomes
Primary Outcome Measures
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.
Root development
Continous root development after on radiographs after intervention
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04000854
First Posted
June 24, 2019
Last Updated
April 7, 2022
Sponsor
Karolinska Institutet
Collaborators
Eastman Dental Insitute and Hospital, Umeå University
1. Study Identification
Unique Protocol Identification Number
NCT04000854
Brief Title
Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis
Official Title
Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis: A Prospective Randomized Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
December 19, 2023 (Anticipated)
Study Completion Date
December 19, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Eastman Dental Insitute and Hospital, Umeå University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regenerative Endodontics in Traumatized Immature Teeth
Keywords
Dental trauma, pulp necrosis, regenerative, endodontics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Calcium hydroxide
Arm Type
Active Comparator
Arm Description
Root canal dressing with Ca(OH)2 (Calasept)
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
Root canal dressing with clorhexidine digluconate 2 % gel
Intervention Type
Drug
Intervention Name(s)
Calcium hydroxide (Calacept)
Other Intervention Name(s)
Clorhexidine digluconate 2 % gel
Intervention Description
Long-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors
Primary Outcome Measure Information:
Title
Apical periodontitis
Description
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
Title
Root development
Description
Continous root development after on radiographs after intervention
Time Frame
Change from baseline radiograph at 12 months
Secondary Outcome Measure Information:
Title
Clinical symptoms
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgios Tsilingaridis, PhD
Phone
0046-8-52488029
Email
georgios.tsilingaridis@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Alina Wikström, PhD-student
Email
alina.wikstrom@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Tsilingaridis, pHd
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastmaninstitutet
City
Stockholm
ZIP/Postal Code
11324
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Wikström, PhD student
Email
alina.wikstrom@sll.se
First Name & Middle Initial & Last Name & Degree
Georgios Tsilingaridis, pHD
Phone
0046-8-52488029
Email
georgios.tsilingaridis@ki.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis
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