Dental Caries in ChildrenPBRNNCT04614285
Partial or Complete Excavation of Deep Caries in Primary Molars
A study testing Partial excavation in people with Dental Caries in Children, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Background: The traditional approach of carious lesions with risk for progression has has been to excavate all infected and demineralised tissue before placement of the restoration. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Partial excavation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2019to 1 Nov 2022
- 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in the age of 3-8 years, with one or more primary molar teeth in a need of a restoration due to a moderate depth of carious lesion;
- caries lesion diagnosed into dentin on radiographs though not exceeding the inner third of the dentin
- caries lesion diagnosed visually with a cavity into dentin.
Who cannot join
- Children with behaviour management problems.
- Teeth with pulpal symptoms
- Teeth expected to exfoliate within the next 18 months
Trial locations and contacts
1 site in 1 country.
Georgios Tsilingaridis, DDS, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Division of Orthodontics and Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet, Sweden
Huddinge, Stockholm County, 141 04
Annika M Julihn, DDS, PhD, +46 70 7941697, annika.julihn@ki.se
Georgios Tsilingaridis, DDS, PhD, georgios.tsilingaridis@ki.se
About this study
Official title: Partial Excavation of Dentin Carious Lesions in Primary Molars: A Practice-Based Research Network (PBRN) Study
Background: The traditional approach of carious lesions with risk for progression has has been to excavate all infected and demineralised tissue before placement of the restoration. In primary teeth, treatment of deep carious lesions is associated with significant risk of pulp lesions and postoperative complications and thus the risk of the teeth being lost. During the past decade, more focus has been on biological methods for caries excavating of deep dentin lesions. An overview comparing different biological methods such as partial or stepwise excavation of deep dentin caries in primary teeth shows that they work as well as traditional methods performing complete caries excavation but have the benefits of reducing the risk of iatrogenic pulp damage [1-3].
Our primary hypothesis is that there is no difference in tooth or filling survival after partial caries excavation compared to complete caries excavation in primary molars.
The secondary hypothesis is that the therapist's knowledge, experience and treatment attitudes and choices are not affected by a participation in the study.
Read the detailed description
The treatment of carious lesions with risk for progression has traditionally been done with caries removal and restorative treatment of the affected teeth. In primary teeth, different treatments for deep carious lesions have been described. Complete excavation aims to removing all infected and demineralised dentin with a high risk of pulpal exposure, postoperative complications and thus the risk of the teeth being lost. In many cases, treatment also involves pain and suffering for the patient, which can lead to dental fear among children.
In latest years there has been a growing evidence for the possibility of controlling the cariogenic biofilm in the lesion by isolating the infected tissue from the oral cavity with an isolating restoration and leaving infected tissue under the permanent restoration. The methods are considered to be able to slow down or arrest the caries progression in primary teeth so that the teeth exfoliate without causing pain or infection. When carious tissue is isolated from the oral environment deprives the residual bacteria from carbohydrates and has thus been shown to have an antibacterial effect and to stop further progression of the lesion [4-5]. Partial, i.e. one-step incomplete or selective excavation is one biological method that seals carious dentin under a definitive restoration, omitting any re-entry. This can thus be a treatment choice for the primary teeth.
An overview comparing different biological methods for caries excavation of deep dentin caries in primary teeth, such as partial or stepwise excavation shows that they work as well as traditional methods performing complete caries excavation but have the benefits of reducing the risk of iatrogenic pulp damage [1-4]. However, partial excavation compared with complete excavation in deep carious lesions in primary teeth has not previously been tested under practice-like conditions. If the study shows that the treatment is effective in clinical practice and in the hands of multiple operators, it will change the routine treatment of dentin caries in primary teeth, thus increasing the survival of teeth and fillings, as well as reducing the risk of unwanted injury to the pulp and pain and discomfort to the children.
Objectives and Hypothesis: The primary purpose of the study is to investigate the sustainability of filling and the tooth survival after two different methods of excavation of dentin caries in primary molars.
The primary hypothesis is that there is no difference in tooth or filling survival after partial caries excavation compared to complete caries excavation in primary molars.
The secondary purpose of the study is to investigate the therapist's knowledge, experience and treatment attitude and choice of treatment method in primary caries excavation and how a participation in the study affects the therapist.
The secondary hypothesis is that the therapist's knowledge, experience and treatment attitudes and choices are not affected by a participation in the study.
The study aims to testing a newly started Practice-Based Research Network (PBRN) within the discipline of pediatric dentistry in the Stockholm city county in Sweden and the county of Östergötland. Thus, the scientific question will be tested under an effectiveness setting including practitioners interested in participating in the PBRN by signing up for participating in this particular study. The study has a prospective multi-center, two arms randomized controlled clinical trial design.
- Conditions
- Dental Caries in Children
- Being tested
- Partial excavation
- Keywords
- Dental caries, Dental treatment, Pediatric dentistry, Practice-based research network, Randomized clinical trial
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial excavationProcedure or surgery
Also called Selective excavation, Incomplete excavation
Operators sign up for participation at the homepage of Center for Pediatric Oral Health Research (ABC). The study will be carried out in a Practice-Based Research Network setting. All practitioners interested in participating in the study will get access to an online information about their participation after they signed up. The participation starts by answering a questionnaire on their treatment attitudes and experiences.
Patients will be identified during the routine dental examination. If a carious lesion in the primary molars is detected and in a need of a restoration, the children and parents will be asked to participate in the study.
The parents receive information about the study and give their consent. Allocation into treatment groups will be performed by random assignment by the homepage of ABC.
After the study is finished the participating dentist will be asked to answer the same questionnaire to investigate the effect of the participation on the operators attitude.
| Study group | Role | What they receive |
|---|---|---|
| Partial excavation | Experimental | The treatment will be performed after applying local anesthetic according to individual needs. The intervention group will receive partial removal of the carious lesion; In the inner part of the lesion, the caries removal will be limited to reach leathery or slightly soft dentin by probing. The restorations will be placed according to evidence based methods and the material used according to the operators material of choice. Receives: Procedure: Partial excavation |
| Complete excavation | Active comparator | The treatment will be performed after applying local anesthetic according to individual needs. The control group will receive the same treatment procedure as the intervention group, but the excavation procedure will include total removal of the carious tissue. The total caries removal will be ensured with hardness on probing and the visual examination. Photographs will be used as benchmark. Receives: Procedure: Partial excavation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
Success will be measured by assessing if the restoration is in place (i.e. tooth in place vs. tooth lost) and without comment.
Measured: 24 months
Tooth survival
Tooth survival will be measured by assessing tooth exfoliation without causing pain or infection.
Measured: 24 months
Secondary outcomes (1)
Decision-making Questionnaire
The Dentist's Knowledge and Attitudes of Deep Carious Lesions in Primary Teeth questionnaire will be used to assess dentists' knowledge, experience, treatment and attitudes and how these factors were affected by participation in the study. The questionnaire is rated on a scale from 1-4, with 1 having the least impact or what the dentist does most rarely, and 4 having the the greatest impact or what the dentist does most often. The questionnaire will be administered at baseline and at 24-month follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Mar 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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
- Model description
- The study has a prospective multi-center, two arms randomized controlled clinical trial design.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annika Julihn, Karolinska Institutet
- Investigators
- Göran Dahllöf, Professor, Principal investigator, Department of Dental Medicine, Karolinska Institutet, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614285
- Sponsor's protocol ID
- Dnr. 2018/743-31/1
- Acronym
- PBRN
- Status last verified
- Nov 2020
- First submitted
- 15 Jun 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franzon R, Guimaraes LF, Magalhaes CE, Haas AN, Araujo FB. Outcomes of one-step incomplete and complete excavation in primary teeth: a 24-month randomized controlled trial. Caries Res. 2014;48(5):376-83. doi: 10.1159/000357628. Epub 2014 Apr 8.
PubMed 24732081Griffin SO, Oong E, Kohn W, Vidakovic B, Gooch BF; CDC Dental Sealant Systematic Review Work Group; Bader J, Clarkson J, Fontana MR, Meyer DM, Rozier RG, Weintraub JA, Zero DT. The effectiveness of sealants in managing caries lesions. J Dent Res. 2008 Feb;87(2):169-74. doi: 10.1177/154405910808700211.
PubMed 18218845Oong EM, Griffin SO, Kohn WG, Gooch BF, Caufield PW. The effect of dental sealants on bacteria levels in caries lesions: a review of the evidence. J Am Dent Assoc. 2008 Mar;139(3):271-8; quiz 357-8. doi: 10.14219/jada.archive.2008.0156.
PubMed 18310731Ricketts D, Lamont T, Innes NP, Kidd E, Clarkson JE. Operative caries management in adults and children. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003808. doi: 10.1002/14651858.CD003808.pub3.
PubMed 23543523Schwendicke F, Dorfer CE, Paris S. Incomplete caries removal: a systematic review and meta-analysis. J Dent Res. 2013 Apr;92(4):306-14. doi: 10.1177/0022034513477425. Epub 2013 Feb 8.
PubMed 23396521
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Excavation of Dentin Carious Lesions in Primary Molars: A Practice-Based Research Network (PBRN) Study
- ClinicalTrials.gov ID
- NCT04614285
- Acronym / sponsor ID
- PBRN / Dnr. 2018/743-31/1
- Conditions
- Dental Caries in Children
- Keywords
- Dental caries, Dental treatment, Pediatric dentistry, Practice-based research network, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 3 Nov 2020 (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.
Background: The traditional approach of carious lesions with risk for progression has has been to excavate all infected and demineralised tissue before placement of the restoration. In primary teeth, treatment of deep carious lesions is associated with significant risk of pulp lesions and postoperative complications and thus the risk of the teeth being lost. During the past decade, more focus has been on biological methods for caries excavating of deep dentin lesions. An overview comparing different biological methods such as partial or stepwise excavation of deep dentin caries in primary teeth shows that they work as well as traditional methods performing complete caries excavation but have the benefits of reducing the risk of iatrogenic pulp damage [1-3].
Our primary hypothesis is that there is no difference in tooth or filling survival after partial caries excavation compared to complete caries excavation in primary molars.
The secondary hypothesis is that the therapist's knowledge, experience and treatment attitudes and choices are not affected by a participation in the study.
Detailed description
The treatment of carious lesions with risk for progression has traditionally been done with caries removal and restorative treatment of the affected teeth. In primary teeth, different treatments for deep carious lesions have been described. Complete excavation aims to removing all infected and demineralised dentin with a high risk of pulpal exposure, postoperative complications and thus the risk of the teeth being lost. In many cases, treatment also involves pain and suffering for the patient, which can lead to dental fear among children.
In latest years there has been a growing evidence for the possibility of controlling the cariogenic biofilm in the lesion by isolating the infected tissue from the oral cavity with an isolating restoration and leaving infected tissue under the permanent restoration. The methods are considered to be able to slow down or arrest the caries progression in primary teeth so that the teeth exfoliate without causing pain or infection. When carious tissue is isolated from the oral environment deprives the residual bacteria from carbohydrates and has thus been shown to have an antibacterial effect and to stop further progression of the lesion [4-5]. Partial, i.e. one-step incomplete or selective excavation is one biological method that seals carious dentin under a definitive restoration, omitting any re-entry. This can thus be a treatment choice for the primary teeth.
An overview comparing different biological methods for caries excavation of deep dentin caries in primary teeth, such as partial or stepwise excavation shows that they work as well as traditional methods performing complete caries excavation but have the benefits of reducing the risk of iatrogenic pulp damage [1-4]. However, partial excavation compared with complete excavation in deep carious lesions in primary teeth has not previously been tested under practice-like conditions. If the study shows that the treatment is effective in clinical practice and in the hands of multiple operators, it will change the routine treatment of dentin caries in primary teeth, thus increasing the survival of teeth and fillings, as well as reducing the risk of unwanted injury to the pulp and pain and discomfort to the children.
Objectives and Hypothesis: The primary purpose of the study is to investigate the sustainability of filling and the tooth survival after two different methods of excavation of dentin caries in primary molars.
The primary hypothesis is that there is no difference in tooth or filling survival after partial caries excavation compared to complete caries excavation in primary molars.
The secondary purpose of the study is to investigate the therapist's knowledge, experience and treatment attitude and choice of treatment method in primary caries excavation and how a participation in the study affects the therapist.
The secondary hypothesis is that the therapist's knowledge, experience and treatment attitudes and choices are not affected by a participation in the study.
The study aims to testing a newly started Practice-Based Research Network (PBRN) within the discipline of pediatric dentistry in the Stockholm city county in Sweden and the county of Östergötland. Thus, the scientific question will be tested under an effectiveness setting including practitioners interested in participating in the PBRN by signing up for participating in this particular study. The study has a prospective multi-center, two arms randomized controlled clinical trial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study has a prospective multi-center, two arms randomized controlled clinical trial design.
| Arm | Type | Receives |
|---|---|---|
| Partial excavation | Experimental | Procedure: Partial excavationThe treatment will be performed after applying local anesthetic according to individual needs. The intervention group will receive partial removal of the carious lesion; In the inner part of the lesion, the caries removal will be limited to reach leathery or slightly soft dentin by probing. The restorations will be placed according to evidence based methods and the material used according to the operators material of choice. |
| Complete excavation | Active comparator | Procedure: Partial excavationThe treatment will be performed after applying local anesthetic according to individual needs. The control group will receive the same treatment procedure as the intervention group, but the excavation procedure will include total removal of the carious tissue. The total caries removal will be ensured with hardness on probing and the visual examination. Photographs will be used as benchmark. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children in the age of 3-8 years, with one or more primary molar teeth in a need of a restoration due to a moderate depth of carious lesion;
Key exclusion criteria (3 listed)
- Children with behaviour management problems.
- Teeth with pulpal symptoms
- Teeth expected to exfoliate within the next 18 months
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 |
|---|---|---|
| Partial excavationAlso: Selective excavation, Incomplete excavationOperators sign up for participation at the homepage of Center for Pediatric Oral Health Research (ABC). The study will be carried out in a Practice-Based Research Network setting. All practitioners interested in participating in the study will get access to an online information about their participation after they signed up. The participation starts by answering a questionnaire on their treatment attitudes and experiences. Patients will be identified during the routine dental examination. If a carious lesion in the primary molars is detected and in a need of a restoration, the children and parents will be asked to participate in the study. The parents receive information about the study and give their consent. Allocation into treatment groups will be performed by random assignment by the homepage of ABC. After the study is finished the participating dentist will be asked to answer the same questionnaire to investigate the effect of the participation on the operators attitude. | Procedure or surgery | Complete excavation, Partial excavation |
Primary outcome
Success
Time frame: 24 months
Success will be measured by assessing if the restoration is in place (i.e. tooth in place vs. tooth lost) and without comment.
Tooth survival
Time frame: 24 months
Tooth survival will be measured by assessing tooth exfoliation without causing pain or infection.
1 secondary outcome
Decision-making Questionnaire
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Background: PubMed 24732081Franzon R, Guimaraes LF, Magalhaes CE, Haas AN, Araujo FB. Outcomes of one-step incomplete and complete excavation in primary teeth: a 24-month randomized controlled trial. Caries Res. 2014;48(5):376-83. doi: 10.1159/000357628. Epub 2014 Apr 8.
- Background: PubMed 18218845Griffin SO, Oong E, Kohn W, Vidakovic B, Gooch BF; CDC Dental Sealant Systematic Review Work Group; Bader J, Clarkson J, Fontana MR, Meyer DM, Rozier RG, Weintraub JA, Zero DT. The effectiveness of sealants in managing caries lesions. J Dent Res. 2008 Feb;87(2):169-74. doi: 10.1177/154405910808700211.
- Background: PubMed 18310731Oong EM, Griffin SO, Kohn WG, Gooch BF, Caufield PW. The effect of dental sealants on bacteria levels in caries lesions: a review of the evidence. J Am Dent Assoc. 2008 Mar;139(3):271-8; quiz 357-8. doi: 10.14219/jada.archive.2008.0156.
- Results publication: PubMed 23543523Ricketts D, Lamont T, Innes NP, Kidd E, Clarkson JE. Operative caries management in adults and children. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003808. doi: 10.1002/14651858.CD003808.pub3.
- Results publication: PubMed 23396521Schwendicke F, Dorfer CE, Paris S. Incomplete caries removal: a systematic review and meta-analysis. J Dent Res. 2013 Apr;92(4):306-14. doi: 10.1177/0022034513477425. Epub 2013 Feb 8.
- Individual participant dataSharing planned: No
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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.
Georgios Tsilingaridis, DDS, PhD contact
Göran Dahllöf, Professor principal investigator
Department of Dental Medicine, Karolinska Institutet, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial excavation in people with Dental Caries in Children, 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 3 inclusion and 3 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 25 Nov 2020. 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 Annika M Julihn, DDS, PhD (+46-70-7941697, annika.julihn@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (time frame: 24 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?
On the ClinicalTrials.gov record for NCT04614285, which also lists 5 linked publications.
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 25 Nov 2020.