Regenerative Endodontics in Traumatized Immature TeethNCT04000854
Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis
A study testing Calcium hydroxide (Calacept) in people with Regenerative Endodontics in Traumatized Immature Teeth, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 19 years
- Conditions the study is for
- Regenerative Endodontics in Traumatized Immature Teeth
- What is being tested?
- Calcium hydroxide (Calacept)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- 19 Feb 2019to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Alina Wikström, PhD-student contact
Sweden1 site, 1 recruiting
- Recruiting
Eastmaninstitutet
Stockholm, 11324
Alina Wikström, PhD student, alina.wikstrom@sll.se
Georgios Tsilingaridis, pHD, 0046-8-52488029, georgios.tsilingaridis@ki.se
About this study
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.
- Being tested
- Calcium hydroxide (Calacept)
- Keywords
- Dental trauma, pulp necrosis, regenerative, endodontics
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium hydroxide (Calacept)Drug
Also called Clorhexidine digluconate 2 % gel
Long-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors
| Study group | Role | What they receive |
|---|---|---|
| Calcium hydroxide | Active comparator | Root canal dressing with Ca(OH)2 (Calasept) Receives: Drug: Calcium hydroxide (Calacept) |
| Chlorhexidine | Active comparator | Root canal dressing with clorhexidine digluconate 2 % gel Receives: Drug: Calcium hydroxide (Calacept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline radiograph at 12 months
Root development
Continous root development after on radiographs after intervention
Measured: Change from baseline radiograph at 12 months
Secondary outcomes (1)
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.
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start19 Feb 2019
- Primary completion19 Dec 2023 (estimated)
- Study completion19 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative Endodontics in Traumatized Immature TeethStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Eastman Dental Insitute and Hospital, Umeå University
- Responsible party
- Principal investigator, Georgios Tsilingaridis, Karolinska Institutet
- Investigators
- Georgios Tsilingaridis, pHd, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000854
- Sponsor's protocol ID
- Regenerative endo 181116
- Status last verified
- Apr 2022
- First submitted
- 24 Jun 2019
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis: A Prospective Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT04000854
- Acronym / sponsor ID
- Regenerative endo 181116
- Keywords
- Dental trauma, pulp necrosis, regenerative, endodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Eastman Dental Insitute and Hospital, Umeå University
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 19 Dec 2023 (estimated)
- Study completion
- 19 Dec 2023 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium hydroxide | Active comparator | Drug: Calcium hydroxide (Calacept)Root canal dressing with Ca(OH)2 (Calasept) |
| Chlorhexidine | Active comparator | Drug: Calcium hydroxide (Calacept)Root canal dressing with clorhexidine digluconate 2 % gel |
Who may qualify
- Ages
- 7 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium hydroxide (Calacept)Also: Clorhexidine digluconate 2 % gelLong-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors | Drug | Calcium hydroxide, Chlorhexidine |
Primary outcome
Apical periodontitis
Time frame: Change from baseline radiograph at 12 months
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
Time frame: Change from baseline radiograph at 12 months
Continous root development after on radiographs after intervention
1 secondary outcome
Clinical symptoms
Time frame: Change from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Wikström, PhD-student contact
Georgios Tsilingaridis, pHd principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium hydroxide (Calacept) in people with Regenerative Endodontics in Traumatized Immature Teeth, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Tsilingaridis, PhD (0046-8-52488029, georgios.tsilingaridis@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apical periodontitis (time frame: Change from baseline radiograph at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.