CariesNCT03833557
Success Rate of Three Capping Materials
A study testing Nanohydroxyapatite Pulpotomy, MTA pulpotomy and Formocresol Pulpotomy in people with Caries, run by Cairo University at 1 site in Egypt.
Trial summary
A randomized clinical trial was carried out on 72 second primary molars indicated for pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) \& the third received Formocresol pulpotomy. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Nanohydroxyapatite Pulpotomy, MTA pulpotomy and Formocresol Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2017to 14 Jan 2019
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Absence of tenderness to percussion.
- Absence of physiologic or pathologic tooth mobility.
- No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.
- Restorable teeth.
- Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection
Who cannot join
- • Evidence of necrosis after access cavity preparation.
- Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Success Rate of Three Capping Materials Used in Pulpotomy of Primary Molars: A Randomized Clinical Trial
A randomized clinical trial was carried out on 72 second primary molars indicated for pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) \& the third received Formocresol pulpotomy. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three , six \& 12 months.
Read the detailed description
The study population included four to eight years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University with mandibular second primary molars indicated for pulpotomy which met specific inclusion and exclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure.
Procedures:
Preoperative periapical radiograph using periapical film size two Speed D Film , was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis.
The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and deroofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with physiologic saline. Pulp homeostasis was achieved using a sterile wet cotton pellet applied for two to three min.
In Group 1:
Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices.
In Group 2:
The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.
Group 3:
A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps.
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation:
All treated patients were followed up at one, three , six \& 12 months after the pulpotomy.
The pulpotomized teeth were judged as clinically successful if they met the following criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth mobility. Radiographic success was defined if there were normal periodontal ligament space, absence of furcation or periapical radiolucency, absence of internal or external root resorption
Statistical analysis:
Data were collected, revised for completeness and logical consistency, tabulated, and statistically analyzed.
- Conditions
- Caries
- Being tested
- Nanohydroxyapatite Pulpotomy, MTA pulpotomy, Formocresol Pulpotomy
- Keywords
- Formocresol, MTA, Nanohydroxyapatite, Pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanohydroxyapatite PulpotomyProcedure or surgery
Biphasic calcium phosphate 500-1000 Um Straumann BoneCeramic
MTA pulpotomyProcedure or surgery
Angleus grey MTA
Formocresol PulpotomyProcedure or surgery
Buckley's Fromocresol. diluted full strength foromocresol
| Study group | Role | What they receive |
|---|---|---|
| Nanohydroxyapatite Pulpotomy | Active comparator | Biphasic calcium phosphate. Straumann BoneCeramic Regenerative Pulpotomy of 24 mandibular second primary molars using Nanohydroxyapatite
In Group 1: 24 mandibular second primary molars Caries removal and deroofing of pulp chamber Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices.
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation: All treated patients were followed up at one, three , six \& 12 months after the pulpotomy Receives: Procedure: Nanohydroxyapatite Pulpotomy |
| MTA Pulpotomy | Active comparator | Angelus Grey MTA , Regenerative Pulpotomy Pulpotomy of 24 mandibular second primary molars using MTA Caries removal and deroofing of pulp chamber The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation at one, three ,six \& 12 months after pulpotomy. Receives: Procedure: MTA pulpotomy |
| Formocresl Pulpotomy | Active comparator | Buckley' s Formocresol , Fixation pulpotomy Pulpotomy of 24 mandibular second primary molars using Formocresol Caries removal and deroofing of pulp chamber
A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps.
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation: All treated patients were followed up at one, three , six \& 12 months after the pulpotomy for clinical and radiographic evaluation. Independently, two examiners evaluated the teeth clinically and radiographically. Receives: Procedure: Formocresol Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
abscence of all clinical signs and symptoms of failure
Measured: 12 Month
Secondary outcomes (1)
Radiographic success rate
Absence of any radiographic signs of failure
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start5 May 2017
- Primary completion10 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CariesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Youssef Abd Al Gawad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833557
- Sponsor's protocol ID
- 181053
- Status last verified
- Apr 2020
- First submitted
- 30 Jan 2019
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study design and procedures
Publications
Abd Al Gawad RY, Hanafy RMH. Success rate of three capping materials used in pulpotomy of primary molars: A randomized clinical trial. Saudi Dent J. 2021 Nov;33(7):560-567. doi: 10.1016/j.sdentj.2020.08.007. Epub 2020 Aug 29.
PubMed 34803301
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rate of Three Capping Materials Used in Pulpotomy of Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03833557
- Acronym / sponsor ID
- 181053
- Conditions
- Caries
- Keywords
- Formocresol, MTA, Nanohydroxyapatite, Pulpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 7 Feb 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.
A randomized clinical trial was carried out on 72 second primary molars indicated for pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) \& the third received Formocresol pulpotomy. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three , six \& 12 months.
Detailed description
The study population included four to eight years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University with mandibular second primary molars indicated for pulpotomy which met specific inclusion and exclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure.
Procedures:
Preoperative periapical radiograph using periapical film size two Speed D Film , was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis.
The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and deroofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with physiologic saline. Pulp homeostasis was achieved using a sterile wet cotton pellet applied for two to three min.
In Group 1:
Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices.
In Group 2:
The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.
Group 3:
A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps.
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation:
All treated patients were followed up at one, three , six \& 12 months after the pulpotomy.
The pulpotomized teeth were judged as clinically successful if they met the following criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth mobility. Radiographic success was defined if there were normal periodontal ligament space, absence of furcation or periapical radiolucency, absence of internal or external root resorption
Statistical analysis:
Data were collected, revised for completeness and logical consistency, tabulated, and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nanohydroxyapatite Pulpotomy | Active comparator | Procedure: Nanohydroxyapatite PulpotomyBiphasic calcium phosphate. Straumann BoneCeramic Regenerative Pulpotomy of 24 mandibular second primary molars using Nanohydroxyapatite In Group 1: 24 mandibular second primary molars Caries removal and deroofing of pulp chamber Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation: All treated patients were followed up at one, three , six \& 12 months after the pulpotomy |
| MTA Pulpotomy | Active comparator | Procedure: MTA pulpotomyAngelus Grey MTA , Regenerative Pulpotomy Pulpotomy of 24 mandibular second primary molars using MTA Caries removal and deroofing of pulp chamber The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation at one, three ,six \& 12 months after pulpotomy. |
| Formocresl Pulpotomy | Active comparator | Procedure: Formocresol PulpotomyBuckley' s Formocresol , Fixation pulpotomy Pulpotomy of 24 mandibular second primary molars using Formocresol Caries removal and deroofing of pulp chamber A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps. All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation: All treated patients were followed up at one, three , six \& 12 months after the pulpotomy for clinical and radiographic evaluation. Independently, two examiners evaluated the teeth clinically and radiographically. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Absence of tenderness to percussion.
Key exclusion criteria (2 listed)
- • Evidence of necrosis after access cavity preparation.
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 |
|---|---|---|
| Nanohydroxyapatite PulpotomyBiphasic calcium phosphate 500-1000 Um Straumann BoneCeramic | Procedure or surgery | Nanohydroxyapatite Pulpotomy |
| MTA pulpotomyAngleus grey MTA | Procedure or surgery | MTA Pulpotomy |
| Formocresol PulpotomyBuckley's Fromocresol. diluted full strength foromocresol | Procedure or surgery | Formocresl Pulpotomy |
Primary outcome
Clinical success rate
Time frame: 12 Month
abscence of all clinical signs and symptoms of failure
1 secondary outcome
Radiographic success rate
Time frame: 12 Month
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 6 Apr 2020.
- Derived from this study: PubMed 34803301Abd Al Gawad RY, Hanafy RMH. Success rate of three capping materials used in pulpotomy of primary molars: A randomized clinical trial. Saudi Dent J. 2021 Nov;33(7):560-567. doi: 10.1016/j.sdentj.2020.08.007. Epub 2020 Aug 29.
- Individual participant dataSharing planned: Yes. Study design and procedures
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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 Nanohydroxyapatite Pulpotomy, MTA pulpotomy and Formocresol Pulpotomy in people with Caries, 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 5 inclusion and 2 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 6 Apr 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 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?
Clinical success rate (time frame: 12 Month). 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 NCT03833557, which also lists 1 linked publication.
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 6 Apr 2020.