Deep CariesNCT04265833
Evaluation of Three Different Pulp Capping Materials in Indirect Pulp Treatment of Primary Teeth
A study testing Biodentine, TheraCal LC and Calcium hydroxide in people with Deep Caries, run by Izmir Katip Celebi University.
Trial summary
The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical trial was to evaluate the clinical, radiographic, and histopathological success of three different pulp-capping materials in one-stage indirect pulp treatment of primary teeth. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Biodentine, TheraCal LC and Calcium hydroxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2015to 7 Jul 2018
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Previously untreated, vital and asymptomatic lower primary molars with deep caries lesions considered likely to result in pulp exposure if they were treated by a single and terminal excavation
- Positive pulp sensibility tested by an electric pulp tester and cold stimulation,
- Mild discomfort from chemical and thermal stimuli,
- Cooperative children and parents willing to follow the instructions and report for follow-up.
Who cannot join
- Signs of irreversible pulpitis (spontaneous pain, prolonged pain response etc.)
- The presence of percussion or palpation sensitivity, pathological mobility, or infection symptoms like fistula or abscess or discoloration in the clinical examination,
- Absence of normal lamina dura and periodontal range, presence of lesion, internal or external resorption or calcification in or around the root in the radiological examination,
- Children with special health care needs.
About this study
Official title: Clinical, Radiographic and Histological Evaluation of Three Different Pulp Capping Materials in Indirect Pulp Treatment of Primary Teeth: A Randomized Clinical Trial
The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical trial was to evaluate the clinical, radiographic, and histopathological success of three different pulp-capping materials in one-stage indirect pulp treatment of primary teeth.
The study included a total of 109 patients aged 5-9 years who had primary teeth with deep carious lesions with or symptoms of irreversible pulpitis. The teeth were divided into three groups according to the pulp-capping agents: (I) Calcium hydroxide (Ca[OH]2) (control group) (n=36), (II) bioactive tricalcium silicate (Biodentine) (n=37), and (III) resin-based tricalcium silicate (TheraCal LC) (n=36). All the teeth were evaluated clinically and radiographically at postoperative months 6, 12, 18, and 24. A total of 23 primary mandibular second molars that were in their regular exfoliation period (24-40 months) were extracted and fixed in 10% formaldehyde solution. The specimens were evaluated histologically to assess the integrity of the odontoblastic layer, tertiary dentin formation and the quality of the dentin formed, severity of pulpitis, and other pulpal changes.
Read the detailed description
Following the clinical and radiographic examinations, pulp vitality was assessed with cold thermal test (Chloraethyl; Wehr, Baden, Germany) and electrical pulp test. After local anesthesia injection, rubber-dam isolation was performed. In the first step of the IPC procedure, cavity preparation was performed and the caries were removed using a high-speed dental handpiece with a diamond bur. In the second step, the carious peripheral dentin was removed at the enamel-dentin junction using a high-speed tungsten-carbide bur and the infected and necrotic soft dentin layer in the center was carefully removed to prevent pulp exposure. Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation, and the demineralized dentin (affected dentin) was left at the floor of the cavity.
After this stage, the teeth were randomly divided into 3 groups:
Ca(OH)2 Group (Control): The residual demineralized dentin was covered with a thin layer of Ca(OH)2 (Dycal; Dentsply/Caulk, Dentsply International Inc. Milford, DE, USA) in accordance with the recommendations of the manufacturer.
Biodentine Group: A thin layer of tricalcium silicate-containing pulp-capping material (Biodentine, Septodont, France) consisting of powder and liquid was applied to the demineralized dentin tissue and a 12-min setting time was allowed for hardening, in accordance with the recommendations of the manufacturer.
TheraCal LC Group: Flowable form of resin-reinforced tricalcium silicate-containing material (TheraCal LC, Bisco Inc, IL, ABD) was applied directly onto the demineralized dentin at a maximum thickness of 1 mm and was polymerized for 20 sec (Valo LED, Ultradent Products Inc., South Jordan, USA), in accordance with the recommendations of the manufacturer.
Afterwards, in all three groups, capsule glass ionomer cement (Capsule; GC Corporation, Tokyo, Japan, Corporation, Tokyo, Japan) was placed on each capping material. Following the etching and bonding process, permanent restoration was finished with composite resin (Filtek Z250 Universal Restorative System, 3M ESPE Dental products, USA).
Histological examination A total of 23 primary mandibular second molars that were in their regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of root formation) (24) and were found to be clinically and radiographically successful following IPC were extracted by the researcher and were processed for histological examination .All the extracted teeth were fixed in 10% formaldehyde solution. Three out of 23 specimens were excluded from the study since they were unsuitable for sectioning.
- Conditions
- Deep Caries
- Being tested
- Biodentine, TheraCal LC, Calcium hydroxide
- Keywords
- deep caries, indirect pulp capping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineOther
Biodentine has been shown to cause increased calcium ion release and this increase has been associated with the presence of pure tricalcium silicate and calcium chloride and the increased Ca(OH)2 formation
TheraCal LCOther
TheraCal LC (Bisco Inc, IL, USA) is a light-cured, resin-modified, calcium silicate-based material designed as a direct/indirect pulp-capping material. This agent has been shown to increase the pH on the pulpal surface thereby stimulating regenerative processes in the pulp, and ultimately contributing to the formation of dentin bridge
Calcium hydroxideOther
Calcium hydroxide (Ca[OH]2) is a successful pulp-capping agent activating the repair mechanism by stimulating the dentin-pulp complex. Ca(OH)2, with its bactericidal effects, protects the complex from bacterial effects and also has a stimulating effect on dentin remineralization
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide | Active comparator | Thirty six primary molar teeth with deep caries lesion were selected to apply indirect pulp therapy with calcium hydroxide. The carious peripheral dentin was removed at the enamel-dentin junction using a high-speed tungsten-carbide bur and the infected and necrotic soft dentin layer in the center was carefully removed to prevent pulp exposure. Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation, and the demineralized dentin (affected dentin) was left at the floor of the cavity.The residual demineralized dentin was covered with a thin layer of Ca(OH)2 (approximately 1 mm2) in accordance with the recommendations of the manufacturer. Afterwards capsule glass ionomer cement was placed on each capping material. Following the etching and bonding process, permanent restoration was finished with composite resin. Receives: Other: Calcium hydroxide |
| Biodentine | Experimental | Thirty seven primary molar teeth were selected to apply indirect pulp therapy with Biodentine. The carious peripheral dentin was removed at the enamel-dentin junction using a high-speed tungsten-carbide-bur and the infected and necrotic soft dentin layer in the center was carefully removed. Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation, and the demineralized dentin (affected dentin) was left at the floor of the cavity. A thin layer of tricalcium silicate-containing pulp-capping material (Biodentine) (approximately 1 mm2) consisting of powder and liquid was applied to the demineralized dentin tissue and a 12-min setting time was allowed for hardening, in accordance with the recommendations of the manufacturer. Afterwards capsule glass ionomer cement was placed on each capping material. Following the etching and bonding process, permanent restoration was finished with composite resin. Receives: Other: Biodentine |
| TheraCal LC | Experimental | Thirty six primary molar teeth with deep caries lesion were selected to apply indirect pulp therapy with TheraCal LC. The carious peripheral dentin was removed at the enamel-dentin junction using a high-speed tungsten-carbide bur and the infected and necrotic soft dentin layer in the center was carefully removed. Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation, and the demineralized dentin (affected dentin) was left at the floor of the cavity. Flowable form of resin-reinforced tricalcium silicate-containing material (TheraCal LC) was applied directly onto the demineralized dentin at a maximum thickness of 1 mm and was polymerized for 20 sec (Valo LED), in accordance with the recommendations of the manufacturer. Afterwards capsule glass ionomer cement was placed on each capping material. Following the etching and bonding process, permanent restoration was finished with composite resin. Receives: Other: TheraCal LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate of indirect pulp treatment
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Measured: Change of clinical success from Baseline at 6 month
Clinical success rate of indirect pulp treatment
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Measured: Change of clinical success from baseline to 12 month
Clinical success rate of indirect pulp treatment
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Measured: Change of clinical success from baseline to 18 month
Clinical success rate of indirect pulp treatment
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Measured: Change of clinical success from baseline to 24 month
Radiographic success rate of indirect pulp treatment
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Measured: Change of radiographic success from baseline to 6 month
Radiographic success rate of indirect pulp treatment
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Measured: Change of radiographic success from baseline to 12 month
Radiographic success rate of indirect pulp treatment
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Measured: Change of radiographic success from baseline to 18 month
Radiographic success rate of indirect pulp treatment
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Measured: Change of radiographic success from baseline to 24 month
Secondary outcomes (1)
Histological success rate of indirect pulp treatment
For histologic evaluation, the treatment is rated as a failure when one or more of the following signs are present: absent of the integrity of the odontoblastic layer, absent of tertiary dentin formation, presence of pulpitis, presence of fibrosis and dystrophic calcification. The treatment is regarded successful if histologic evaluation does not indicate any signs of failure.
Measured: up to 40 months (the teeth were extracted in regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of root formation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start8 Feb 2015
- Primary completion15 Sep 2015
- Study completion7 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- 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
- randomized, three-arm parallel, two-blinded clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve AKCAY, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265833
- Sponsor's protocol ID
- 2014-1-TEZ-54
- Status last verified
- Feb 2020
- First submitted
- 26 Dec 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Histological Evaluation of Three Different Pulp Capping Materials in Indirect Pulp Treatment of Primary Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04265833
- Acronym / sponsor ID
- 2014-1-TEZ-54
- Conditions
- Deep Caries
- Keywords
- deep caries, indirect pulp capping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 8 Feb 2015 (actual)
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 12 Feb 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.
The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical trial was to evaluate the clinical, radiographic, and histopathological success of three different pulp-capping materials in one-stage indirect pulp treatment of primary teeth.
The study included a total of 109 patients aged 5-9 years who had primary teeth with deep carious lesions with or symptoms of irreversible pulpitis. The teeth were divided into three groups according to the pulp-capping agents: (I) Calcium hydroxide (Ca[OH]2) (control group) (n=36), (II) bioactive tricalcium silicate (Biodentine) (n=37), and (III) resin-based tricalcium silicate (TheraCal LC) (n=36). All the teeth were evaluated clinically and radiographically at postoperative months 6, 12, 18, and 24. A total of 23 primary mandibular second molars that were in their regular exfoliation period (24-40 months) were extracted and fixed in 10% formaldehyde solution. The specimens were evaluated histologically to assess the integrity of the odontoblastic layer, tertiary dentin formation and the quality of the dentin formed, severity of pulpitis, and other pulpal changes.
Detailed description
Following the clinical and radiographic examinations, pulp vitality was assessed with cold thermal test (Chloraethyl; Wehr, Baden, Germany) and electrical pulp test. After local anesthesia injection, rubber-dam isolation was performed. In the first step of the IPC procedure, cavity preparation was performed and the caries were removed using a high-speed dental handpiece with a diamond bur. In the second step, the carious peripheral dentin was removed at the enamel-dentin junction using a high-speed tungsten-carbide bur and the infected and necrotic soft dentin layer in the center was carefully removed to prevent pulp exposure. Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation, and the demineralized dentin (affected dentin) was left at the floor of the cavity.
After this stage, the teeth were randomly divided into 3 groups:
Ca(OH)2 Group (Control): The residual demineralized dentin was covered with a thin layer of Ca(OH)2 (Dycal; Dentsply/Caulk, Dentsply International Inc. Milford, DE, USA) in accordance with the recommendations of the manufacturer.
Biodentine Group: A thin layer of tricalcium silicate-containing pulp-capping material (Biodentine, Septodont, France) consisting of powder and liquid was applied to the demineralized dentin tissue and a 12-min setting time was allowed for hardening, in accordance with the recommendations of the manufacturer.
TheraCal LC Group: Flowable form of resin-reinforced tricalcium silicate-containing material (TheraCal LC, Bisco Inc, IL, ABD) was applied directly onto the demineralized dentin at a maximum thickness of 1 mm and was polymerized for 20 sec (Valo LED, Ultradent Products Inc., South Jordan, USA), in accordance with the recommendations of the manufacturer.
Afterwards, in all three groups, capsule glass ionomer cement (Capsule; GC Corporation, Tokyo, Japan, Corporation, Tokyo, Japan) was placed on each capping material. Following the etching and bonding process, permanent restoration was finished with composite resin (Filtek Z250 Universal Restorative System, 3M ESPE Dental products, USA).
Histological examination A total of 23 primary mandibular second molars that were in their regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of root formation) (24) and were found to be clinically and radiographically successful following IPC were extracted by the researcher and were processed for histological examination .All the extracted teeth were fixed in 10% formaldehyde solution. Three out of 23 specimens were excluded from the study since they were unsuitable for sectioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, three-arm parallel, two-blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide | Active comparator | Other: Calcium hydroxideThirty six primary molar teeth with deep caries lesion were selected to apply indirect pulp therapy with calcium hydroxide. The carious peripheral dentin was removed at the enamel-dentin junction using a high-speed tungsten-carbide bur and the infected and necrotic soft dentin layer in the center was carefully removed to prevent pulp exposure. Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation, and the demineralized dentin (affected dentin) was left at the floor of the cavity.The residual demineralized dentin was covered with a thin layer of Ca(OH)2 (approximately 1 mm2) in accordance with the recommendations of the manufacturer. Afterwards capsule glass ionomer cement was placed on each capping material. Following the etching and bonding process, permanent restoration was finished with composite resin. |
| Biodentine | Experimental | Other: BiodentineThirty seven primary molar teeth were selected to apply indirect pulp therapy with Biodentine. The carious peripheral dentin was removed at the enamel-dentin junction using a high-speed tungsten-carbide-bur and the infected and necrotic soft dentin layer in the center was carefully removed. Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation, and the demineralized dentin (affected dentin) was left at the floor of the cavity. A thin layer of tricalcium silicate-containing pulp-capping material (Biodentine) (approximately 1 mm2) consisting of powder and liquid was applied to the demineralized dentin tissue and a 12-min setting time was allowed for hardening, in accordance with the recommendations of the manufacturer. Afterwards capsule glass ionomer cement was placed on each capping material. Following the etching and bonding process, permanent restoration was finished with composite resin. |
| TheraCal LC | Experimental | Other: TheraCal LCThirty six primary molar teeth with deep caries lesion were selected to apply indirect pulp therapy with TheraCal LC. The carious peripheral dentin was removed at the enamel-dentin junction using a high-speed tungsten-carbide bur and the infected and necrotic soft dentin layer in the center was carefully removed. Cavity excavation was stopped when the residual dentin over the pulp tissue showed increased resistance to manual instrumentation, and the demineralized dentin (affected dentin) was left at the floor of the cavity. Flowable form of resin-reinforced tricalcium silicate-containing material (TheraCal LC) was applied directly onto the demineralized dentin at a maximum thickness of 1 mm and was polymerized for 20 sec (Valo LED), in accordance with the recommendations of the manufacturer. Afterwards capsule glass ionomer cement was placed on each capping material. Following the etching and bonding process, permanent restoration was finished with composite resin. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Previously untreated, vital and asymptomatic lower primary molars with deep caries lesions considered likely to result in pulp exposure if they were treated by a single and terminal excavation
- Positive pulp sensibility tested by an electric pulp tester and cold stimulation,
- Mild discomfort from chemical and thermal stimuli,
- Cooperative children and parents willing to follow the instructions and report for follow-up.
Key exclusion criteria (4 listed)
- Signs of irreversible pulpitis (spontaneous pain, prolonged pain response etc.)
- The presence of percussion or palpation sensitivity, pathological mobility, or infection symptoms like fistula or abscess or discoloration in the clinical examination,
- Absence of normal lamina dura and periodontal range, presence of lesion, internal or external resorption or calcification in or around the root in the radiological examination,
- Children with special health care needs.
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 |
|---|---|---|
| BiodentineBiodentine has been shown to cause increased calcium ion release and this increase has been associated with the presence of pure tricalcium silicate and calcium chloride and the increased Ca(OH)2 formation | Other | Biodentine |
| TheraCal LCTheraCal LC (Bisco Inc, IL, USA) is a light-cured, resin-modified, calcium silicate-based material designed as a direct/indirect pulp-capping material. This agent has been shown to increase the pH on the pulpal surface thereby stimulating regenerative processes in the pulp, and ultimately contributing to the formation of dentin bridge | Other | TheraCal LC |
| Calcium hydroxideCalcium hydroxide (Ca[OH]2) is a successful pulp-capping agent activating the repair mechanism by stimulating the dentin-pulp complex. Ca(OH)2, with its bactericidal effects, protects the complex from bacterial effects and also has a stimulating effect on dentin remineralization | Other | calcium hydroxide |
Primary outcome
Clinical success rate of indirect pulp treatment
Time frame: Change of clinical success from Baseline at 6 month
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Clinical success rate of indirect pulp treatment
Time frame: Change of clinical success from baseline to 12 month
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Clinical success rate of indirect pulp treatment
Time frame: Change of clinical success from baseline to 18 month
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Clinical success rate of indirect pulp treatment
Time frame: Change of clinical success from baseline to 24 month
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Radiographic success rate of indirect pulp treatment
Time frame: Change of radiographic success from baseline to 6 month
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Radiographic success rate of indirect pulp treatment
Time frame: Change of radiographic success from baseline to 12 month
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Radiographic success rate of indirect pulp treatment
Time frame: Change of radiographic success from baseline to 18 month
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Radiographic success rate of indirect pulp treatment
Time frame: Change of radiographic success from baseline to 24 month
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
1 secondary outcome
Histological success rate of indirect pulp treatment
Time frame: up to 40 months (the teeth were extracted in regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of root formation).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine, TheraCal LC and Calcium hydroxide in people with Deep Caries, run by Izmir Katip Celebi University.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate of indirect pulp treatment (time frame: Change of clinical success from Baseline at 6 month). The study lists 8 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 12 Feb 2020.