Pulp Disease, DentalNCT03582319
Clinical and Radiographic Evaluation of Biodentine Versus Formocresol
A study testing Biodentine and Formocresol in people with Pulp Disease, Dental, run by Cairo University at 1 site in Egypt.
Trial summary
Aim of the study: To compare Formocresol and Biodentine clinically and radiographically when used for pulpotomy of primary molars Study Design : A randomized control clinical trial (split mouth and double blind) was conducted on 43 (4-6 years-old) children with decayed vital mandibular primary molars which were… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- Biodentine and Formocresol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2017to 22 Feb 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children between 4 and 6 years of age with two matched bilateral deep carious primary mandibular first or second molars.
- No evident clinical symptoms of pulpal necrosis or pulp degeneration such as pain on percussion, spontaneous pain, history of swelling or presence of sinus tract.
- No pathologic or physiologic mobility.
- No radiographic evidence of internal and external resorption, pulp stone, and interradicular or periapical lesions (Preoperative radiograph).
- The remaining tooth structure would be restorable with a stainless steel crown.
- Bleeding time after amputation of the coronal pulp tissue was within normal limits (5 minutes).
Who cannot join
- Bleeding time after amputation of the coronal pulp tissue exceed normal limits (5 minutes).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Biodentine Versus Formocresol in Vital Pulpotomy of Primary Molars: (A Randomized Control Clinical Trial)
Aim of the study: To compare Formocresol and Biodentine clinically and radiographically when used for pulpotomy of primary molars Study Design : A randomized control clinical trial (split mouth and double blind) was conducted on 43 (4-6 years-old) children with decayed vital mandibular primary molars which were treated by pulpotomy using both medicaments . All treated teeth were followed for one year (at 3, 6, 9 and 12 months clinically and at 6 and 9 radiographically).
Read the detailed description
Study design Randomized clinical trial, double blinded using split mouth technique. Study setting This study was carried out in Pediatric Dentistry Department-Faculty of Dentistry-Cairo University- Egypt.
Patients
Patients recruited for this study were selected according to the following criteria:
- Healthy children between 4 and 6 years of age with two matched bilateral deep carious primary mandibular first or second molars.
- No evident clinical symptoms of pulpal necrosis or pulp degeneration such as pain on percussion, spontaneous pain, history of swelling or presence of sinus tract.
- No pathologic or physiologic mobility.
- No radiographic evidence of internal and external resorption, pulp stone, and interradicular or periapical lesions (Preoperative radiograph).
- The remaining tooth structure would be restorable with a stainless steel crown.
- Bleeding time after amputation of the coronal pulp tissue was within normal limits (5 minutes).
Sample size calculation using sealedenvelop.com, (30) the online sample calculator, sample size was calculated assuming the null hypothesis that biodentine and formocresol have an average success rate of 95,99 % and 87.8 % respectively (26, 31,32,33). Thus planning a binary outcome non inferiority trial with a difference of 8.19 %, then 76 primary molars (38 per group) are required to be 90% sure that the upper limit of a one-sided 95% confidence interval will exclude a difference in favor of the standard group of more than 10% (34).
With an estimation of 10% annual dropout, sample size was set to 86 primary molars (43 per group) (35). Forty three children with the matching criteria of patient selection were included in this study.
Research Ethics Committee approval was obtained from Faculty of Dentistry Cairo University. Detailed treatment plan and procedures were explained to the parents and informed written consent s were obtained before practical work.
Randomization Using 4 times folded papers in which one of the tested materials was written (43 paper for each material) contained in a closed white envelops (43 envelop in each one folded paper of each tested materials were placed), the selected two matched bilateral deep carious primary mandibular molars were randomly allocated to one of the tested materials.
When guardians agreed for their child to participate in the trial, an envelope was drowned and patient personal data was written on it. At the time of treatment of the first tooth in each patient, one of the folded papers was taken from the envelope and the type of the dressing material was recorded. Trial participant and outcome assessors were blinded to the type of materials used in each tooth.
- Conditions
- Pulp Disease, Dental
- Being tested
- Biodentine, Formocresol
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineOther
Biodentine is mainly composed of tricalcium silicate, calcium carbonate and zirconium oxides while the liquid contains calcium chloride as the setting accelerator and water reducing agent
FormocresolOther
Also called Tricresol formalin
Formocresol is a devitalizing and fixing agent which was introduced to dentistry since 1904 with full concentration of Buckley's formula (19% formaldehyde, 35 % cresol, and 15 % glycerin in distilled water). A five times diluted formula of Buckley's formocresol was used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | Regenerative material for pulp therapy Receives: Other: Biodentine |
| Formocresol | Active comparator | Fixative agent for pulp therapy Receives: Other: Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing survival rate regarding absence of spontaneous pain over time. using a questionnaire.
measurement of survival rate regarding absence of spontaneous pain and assessing the change over time ( binary outcome measured by direct questioning to the patient.
Measured: 3,6,9 and12 months.
Secondary outcomes (4)
Assessing absence of abscess, fistula or pathologic mobility over time using visual and clinical examination.
Absence of abscess, fistula or pathologic mobility ( binary outcome measured by visual and clinical examination).
Measured: 3, 6, 9 and 12 months.
Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ).
Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ) with assessment of change over time.
Measured: 6 and 12 months.
Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) .
Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) with assessment of change over time.
Measured: 6 and 12 months
Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) .
Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) with assessment of change over time.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start12 Feb 2017
- Primary completion20 Jan 2018
- Study completion22 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Randomized clinical trial, double blinded using split mouth technique.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Abdel Azeem Elbardissy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582319
- Sponsor's protocol ID
- Abardissy
- Status last verified
- Jun 2018
- First submitted
- 3 Jun 2018
- Last updated
- 11 Jul 2018
- Results posted
- 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 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Biodentine Versus Formocresol in Vital Pulpotomy of Primary Molars: (A Randomized Control Clinical Trial)
- ClinicalTrials.gov ID
- NCT03582319
- Acronym / sponsor ID
- Abardissy
- Conditions
- Pulp Disease, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 11 Jul 2018 (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.
Aim of the study: To compare Formocresol and Biodentine clinically and radiographically when used for pulpotomy of primary molars Study Design : A randomized control clinical trial (split mouth and double blind) was conducted on 43 (4-6 years-old) children with decayed vital mandibular primary molars which were treated by pulpotomy using both medicaments . All treated teeth were followed for one year (at 3, 6, 9 and 12 months clinically and at 6 and 9 radiographically).
Detailed description
Study design Randomized clinical trial, double blinded using split mouth technique. Study setting This study was carried out in Pediatric Dentistry Department-Faculty of Dentistry-Cairo University- Egypt.
Patients
Patients recruited for this study were selected according to the following criteria:
- Healthy children between 4 and 6 years of age with two matched bilateral deep carious primary mandibular first or second molars.
- No evident clinical symptoms of pulpal necrosis or pulp degeneration such as pain on percussion, spontaneous pain, history of swelling or presence of sinus tract.
- No pathologic or physiologic mobility.
- No radiographic evidence of internal and external resorption, pulp stone, and interradicular or periapical lesions (Preoperative radiograph).
- The remaining tooth structure would be restorable with a stainless steel crown.
- Bleeding time after amputation of the coronal pulp tissue was within normal limits (5 minutes).
Sample size calculation using sealedenvelop.com, (30) the online sample calculator, sample size was calculated assuming the null hypothesis that biodentine and formocresol have an average success rate of 95,99 % and 87.8 % respectively (26, 31,32,33). Thus planning a binary outcome non inferiority trial with a difference of 8.19 %, then 76 primary molars (38 per group) are required to be 90% sure that the upper limit of a one-sided 95% confidence interval will exclude a difference in favor of the standard group of more than 10% (34).
With an estimation of 10% annual dropout, sample size was set to 86 primary molars (43 per group) (35). Forty three children with the matching criteria of patient selection were included in this study.
Research Ethics Committee approval was obtained from Faculty of Dentistry Cairo University. Detailed treatment plan and procedures were explained to the parents and informed written consent s were obtained before practical work.
Randomization Using 4 times folded papers in which one of the tested materials was written (43 paper for each material) contained in a closed white envelops (43 envelop in each one folded paper of each tested materials were placed), the selected two matched bilateral deep carious primary mandibular molars were randomly allocated to one of the tested materials.
When guardians agreed for their child to participate in the trial, an envelope was drowned and patient personal data was written on it. At the time of treatment of the first tooth in each patient, one of the folded papers was taken from the envelope and the type of the dressing material was recorded. Trial participant and outcome assessors were blinded to the type of materials used in each tooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial, double blinded using split mouth technique.
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Other: BiodentineRegenerative material for pulp therapy |
| Formocresol | Active comparator | Other: FormocresolFixative agent for pulp therapy |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy children between 4 and 6 years of age with two matched bilateral deep carious primary mandibular first or second molars.
- No evident clinical symptoms of pulpal necrosis or pulp degeneration such as pain on percussion, spontaneous pain, history of swelling or presence of sinus tract.
- No pathologic or physiologic mobility.
- No radiographic evidence of internal and external resorption, pulp stone, and interradicular or periapical lesions (Preoperative radiograph).
- The remaining tooth structure would be restorable with a stainless steel crown.
Key exclusion criteria (1 listed)
- Bleeding time after amputation of the coronal pulp tissue exceed normal limits (5 minutes).
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 is mainly composed of tricalcium silicate, calcium carbonate and zirconium oxides while the liquid contains calcium chloride as the setting accelerator and water reducing agent | Other | Biodentine |
| FormocresolAlso: Tricresol formalinFormocresol is a devitalizing and fixing agent which was introduced to dentistry since 1904 with full concentration of Buckley's formula (19% formaldehyde, 35 % cresol, and 15 % glycerin in distilled water). A five times diluted formula of Buckley's formocresol was used in this study. | Other | Formocresol |
Primary outcome
Assessing survival rate regarding absence of spontaneous pain over time. using a questionnaire.
Time frame: 3,6,9 and12 months.
measurement of survival rate regarding absence of spontaneous pain and assessing the change over time ( binary outcome measured by direct questioning to the patient.
4 secondary outcomes
Assessing absence of abscess, fistula or pathologic mobility over time using visual and clinical examination.
Time frame: 3, 6, 9 and 12 months.
Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ).
Time frame: 6 and 12 months.
Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) .
Time frame: 6 and 12 months
Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) .
Time frame: 6 and 12 months
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 11 Jul 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine and Formocresol in people with Pulp Disease, Dental, run by Cairo University at 1 site in Egypt.
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 1 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 11 Jul 2018. 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 Egypt. 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?
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?
Assessing survival rate regarding absence of spontaneous pain over time. using a questionnaire. (time frame: 3,6,9 and12 months.). 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 11 Jul 2018.