Decayed Primary MolarsPhase 4NCT05190783
Partial Versus Complete Pulpotomy Using Three Different Materials in Primary Molars: a Clinical Study
A Phase 4 study testing Formocresol, MTA and TheraCal in people with Decayed Primary Molars, run by Mansoura University at 1 site in Egypt.
Trial summary
The purposes of the study to compare partial pulpotomy versus complete pulpotomy in primary molars using three different materials (Formocresol, MTA, Theracal LC) . After 6, 9, 12 and 15 months follow up each case will be evaluated radiographically and clinically. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Decayed Primary Molars
- What is being tested?
- Formocresol, MTA and TheraCal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Nov 2021
- Phase
- Phase 4
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No history of spontaneous or nocturnal pain.
- History of transient pain of sensitivity resulting from various stimuli: hot, cold and sweets.
- Patient who had a bilateral deep carious lesion at second primary molars.
- absence of tenderness to percussion
- absence of physiologic or pathologic tooth mobility
- Radiographic evidence of no internal or external resorption.
- There is not an intraradicular or periapical bone loss or widening of the periodontal ligament space.
Who cannot join
- history of spontaneous or nocturnal pain.
- Patient who had a unilateral deep carious lesion.
- presence of tenderness to percussion
- presence of physiologic or pathologic tooth mobility
- Radiographic evidence of internal or external resorption.
- There is an intraradicular or periapical bone loss or widening of the periodontal ligament space.
Trial locations and contacts
1 site in 1 country.
About this study
The purposes of the study to compare partial pulpotomy versus complete pulpotomy in primary molars using three different materials (Formocresol, MTA, Theracal LC) . After 6, 9, 12 and 15 months follow up each case will be evaluated radiographically and clinically. the radiographic criteria to be evaluated are (radiolucency, resorption, widening in periodontal ligament space, Crypt involvement) and clinical criteria are ( pain, tenderness, fistula, abnormal mobility) upon these criteria some recommendations will be made on success and failure rate of each material and each technique.
Read the detailed description
In children, deep carious lesions represent the most common disease of primary teeth; 42% of children aged 2 to 11 have dental carious lesions in their primary teeth, with an average of 1.6 decayed teeth per child. The most important objective of pediatric dentistry treatment is the preservation of functional primary teeth until natural exfoliation. In the era of conservative dentistry we are now focusing on repair rather than replacement.
Challenges regarding the best treatment modality in primary molars with deep carious lesions that are free of signs or symptoms have continued over the years. Based on a recent systematic review and a new American Academy of Pediatric Dentistry (AAPD) Guideline for vital pulp therapy in primary teeth, indirect pulp therapy (IPT), direct pulp cap (DPC), and pulpotomy are all viable options for treating the pulp in primary teeth with deep carious lesions.
Partial pulpotomy (PP) was originally a means of preserving the remaining coronal and radicular pulp tissues in permanent teeth after a traumatic pulp exposure. In 1982, Cvek introduced this technique for permanent traumatized teeth with complicated crown fracture, which involved removing two mm of pulp and then dressing the non-inflamed pulp with calcium hydroxide. However, according to the new AAPD best practices recommendation, PP is also indicated in young permanent teeth with a carious pulp exposure in which pulpal bleeding can be controlled within several minutes.
Calcium Hydroxide PP of primary molar teeth with deep carious lesions is used in studies conducted by Schroder and Trairatvorakul. Schroder. showed that the clinical-radiographic success rate of primary molar teeth one year after PP was 83 percent; they concluded that PP has the same favorable outcome as cervical formocresol pulpotomy (FP).
If the pulp is diagnosed as normal or as having reversible pulpitis, a new regenerative material is recommended as the dressing material. In comparison with complete pulpotomy (i.e., removal of the entire pulp chamber), PP has several advantages; it causes limited injury to the pulp and limited loss of tooth substances, and this is important for pulpal healing and easier restoration.
Pulpotomy is the pulp treatment most commonly used for primary teeth with a deep carious lesion approaching the pulp. With pulpotomy, a portion of the pulp is removed: the coronal pulp is removed and the radicular pulp is preserved. After treatment, the cavity is filled with a medicament followed by a final restoration.
Formocresol pulpotomy (FCP) was developed in 1932 by Charles A. Sweet.". The original FCP was a three-appointment procedure which has been reduced to a one-appointment procedure; it is still the most common treatment for primary teeth with caries approaching the pulp.
Studies have shown formocresol therapy to have a success rate between 70% and 90%.Histologic results have been variable in contrast to the high clinical success rate. Formocresol is still considered a gold standard by which all new modalities are compared.
MTA is used in pulp capping whether indirect or directly it has the advantage of biocompatibility to the pulp tissues and stimulates the odontoblast for thicker secondary dentine formation without tunnel defects and formation of hydroxyapatite like material to seal the pulp tissues. Although it has slow setting time, discolor the tooth, relatively high cost compared to the gold stander calcium hydroxide.
TheraCal light Cured (LC) is a single paste calcium silicate-based material promoted by the manufacturer for use as a pulp capping agent and as a protective liner for use with restorative materials, cement, or other base materials. The material might be very likable for clinicians because of its ease of handling. According to Alberto Danga in 2009 the cytotoxic effect of resin-based light-cured (Theracal) on human pulp tissue was least when compared to other materials.
There is a lack of evidence in partial pulpotomy treating primary teeth. In this study a Randomized control trial will be performed to have an evidence based answer for treating primary teeth with partial pulpotomy.
- Conditions
- Decayed Primary Molars
- Being tested
- Formocresol, MTA, TheraCal, pulpotomy, partial pulpotomy
- Keywords
- Partial Pulpotomy, pulpotomy, MTA, Theracal, Formocresol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormocresolDrug
mixture of formalin, cresol and glycerine used for fixation of pulp tissues
MTADrug
Also called Mineral trioxide aggregate
material used for pulp regeneration, direct and indirect pulp capping
TheraCalDrug
light cured resin modified calcium silicate filled liner designed for use in direct and indirect pulp capping
pulpotomyProcedure or surgery
removal of the carious tooth structure and unroofing of the pulp chamber with a round carbide bur with high speed and water spray. The coronal pulp tissue will be then removed using a #4 carbide bur with slow speed and sharp spoon excavator.
partial pulpotomyProcedure or surgery
complete removal of caries till exposure occurs. The exposed surface of the pulp will be gently removed using a sterile round diamond bur and a high-speed, water-cooled handpiece with light hand pressure. The removal of the pulp did not exceed approximately two mm.
| Study group | Role | What they receive |
|---|---|---|
| formocresol pulpotomy | Experimental | gold standard arm which pulpotomy will be done with formocresol Receives: Drug: Formocresol; Procedure: pulpotomy |
| formocresol partial pulpotomy | Active comparator | partial pulpotomy will be done with formocresol Receives: Drug: Formocresol; Procedure: partial pulpotomy |
| MTA pulpotomy | Active comparator | in this group complete pulpotomy will be done with MTA Receives: Drug: MTA; Procedure: pulpotomy |
| MTA partial pulpotomy | Active comparator | in this study group partial pulpotomy will be done with MTA Receives: Drug: MTA; Procedure: partial pulpotomy |
| pulpotomy with Theracal LC | Active comparator | in this study group complete pulpotomy will be done with Theracal LC Receives: Drug: TheraCal; Procedure: pulpotomy |
| partial pulpotomy with Theracal LC | Active comparator | in this study group partial pulpotomy technique will be done with Theracal LC Receives: Drug: TheraCal; Procedure: partial pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
numerical/visual analogue scale 0 no pain 10 worst possible pain
Measured: 15 months
Secondary outcomes (7)
radiolucency
measuring tool is periapical xray
Measured: 15 months
fistula
visual inspection
Measured: 15 months
tooth mobility
clinical method of assessing tooth mobility 0 no mobility 3 mobility more than 2 mm bucco-lingualy
Measured: 15 months
tenderness
percussion test with numerical/visual analogue scale 0 no pain 10 worst possible pain
Measured: 15 months
root resorption
periapical xray
Measured: 15 months
widening in periodontal ligament space
periapical xray
Measured: 15 months
permanent tooth crypt involvement
periapical xray
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Mar 2019
- Primary completion1 Aug 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Decayed Primary MolarsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190783
- Sponsor's protocol ID
- PVCPUTDMIPMACS
- Status last verified
- Feb 2019
- First submitted
- 11 Dec 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planning to publish my paper on pediatric dental journals
Publications
Smail-Faugeron V, Porot A, Muller-Bolla M, Courson F. Indirect pulp capping versus pulpotomy for treating deep carious lesions approaching the pulp in primary teeth: a systematic review. Eur J Paediatr Dent. 2016 Jun;17(2):107-12.
PubMed 27377108Katz CR, de Andrade Mdo R, Lira SS, Ramos Vieira EL, Heimer MV. The concepts of minimally invasive dentistry and its impact on clinical practice: a survey with a group of Brazilian professionals. Int Dent J. 2013 Apr;63(2):85-90. doi: 10.1111/idj.12018. Epub 2013 Mar 12.
PubMed 23550521Dhar V, Marghalani AA, Crystal YO, Kumar A, Ritwik P, Tulunoglu O, Graham L. Use of Vital Pulp Therapies in Primary Teeth with Deep Caries Lesions. Pediatr Dent. 2017 Sep 15;39(5):146-159.
PubMed 29070150Cvek M, Cleaton-Jones PE, Austin JC, Andreasen JO. Pulp reactions to exposure after experimental crown fractures or grinding in adult monkeys. J Endod. 1982 Sep;8(9):391-7. doi: 10.1016/S0099-2399(82)80092-7. No abstract available.
PubMed 6957533Schroder U, Szpringer-Nodzak M, Janicha J, Wacinska M, Budny J, Mlosek K. A one-year follow-up of partial pulpotomy and calcium hydroxide capping in primary molars. Endod Dent Traumatol. 1987 Dec;3(6):304-6. doi: 10.1111/j.1600-9657.1987.tb00639.x. No abstract available.
PubMed 3481571Parirokh M, Torabinejad M, Dummer PMH. Mineral trioxide aggregate and other bioactive endodontic cements: an updated overview - part I: vital pulp therapy. Int Endod J. 2018 Feb;51(2):177-205. doi: 10.1111/iej.12841. Epub 2017 Sep 21.
PubMed 28836288Camp JH. Diagnosis dilemmas in vital pulp therapy: treatment for the toothache is changing, especially in young, immature teeth. J Endod. 2008 Jul;34(7 Suppl):S6-12. doi: 10.1016/j.joen.2008.03.020.
PubMed 18565375Wunsch PB, Kuhnen MM, Best AM, Brickhouse TH. Retrospective Study of the Survival Rates of Indirect Pulp Therapy Versus Different Pulpotomy Medicaments. Pediatr Dent. 2016 Oct 15;38(5):406-411.
PubMed 28206897George V, Janardhanan SK, Varma B, Kumaran P, Xavier AM. Clinical and radiographic evaluation of indirect pulp treatment with MTA and calcium hydroxide in primary teeth (in-vivo study). J Indian Soc Pedod Prev Dent. 2015 Apr-Jun;33(2):104-10. doi: 10.4103/0970-4388.155118.
PubMed 25872627El Meligy OA, Allazzam S, Alamoudi NM. Comparison between biodentine and formocresol for pulpotomy of primary teeth: A randomized clinical trial. Quintessence Int. 2016;47(7):571-80. doi: 10.3290/j.qi.a36095.
PubMed 27175451Poggio C, Arciola CR, Beltrami R, Monaco A, Dagna A, Lombardini M, Visai L. Cytocompatibility and antibacterial properties of capping materials. ScientificWorldJournal. 2014;2014:181945. doi: 10.1155/2014/181945. Epub 2014 May 18.
PubMed 24959601
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Versus Complete Pulpotomy Using Three Different Materials in Primary Molars: a Clinical Study
- ClinicalTrials.gov ID
- NCT05190783
- Acronym / sponsor ID
- PVCPUTDMIPMACS
- Conditions
- Decayed Primary Molars
- Keywords
- Partial Pulpotomy, pulpotomy, MTA, Theracal, Formocresol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 13 Jan 2022 (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 purposes of the study to compare partial pulpotomy versus complete pulpotomy in primary molars using three different materials (Formocresol, MTA, Theracal LC) . After 6, 9, 12 and 15 months follow up each case will be evaluated radiographically and clinically. the radiographic criteria to be evaluated are (radiolucency, resorption, widening in periodontal ligament space, Crypt involvement) and clinical criteria are ( pain, tenderness, fistula, abnormal mobility) upon these criteria some recommendations will be made on success and failure rate of each material and each technique.
Detailed description
In children, deep carious lesions represent the most common disease of primary teeth; 42% of children aged 2 to 11 have dental carious lesions in their primary teeth, with an average of 1.6 decayed teeth per child. The most important objective of pediatric dentistry treatment is the preservation of functional primary teeth until natural exfoliation. In the era of conservative dentistry we are now focusing on repair rather than replacement.
Challenges regarding the best treatment modality in primary molars with deep carious lesions that are free of signs or symptoms have continued over the years. Based on a recent systematic review and a new American Academy of Pediatric Dentistry (AAPD) Guideline for vital pulp therapy in primary teeth, indirect pulp therapy (IPT), direct pulp cap (DPC), and pulpotomy are all viable options for treating the pulp in primary teeth with deep carious lesions.
Partial pulpotomy (PP) was originally a means of preserving the remaining coronal and radicular pulp tissues in permanent teeth after a traumatic pulp exposure. In 1982, Cvek introduced this technique for permanent traumatized teeth with complicated crown fracture, which involved removing two mm of pulp and then dressing the non-inflamed pulp with calcium hydroxide. However, according to the new AAPD best practices recommendation, PP is also indicated in young permanent teeth with a carious pulp exposure in which pulpal bleeding can be controlled within several minutes.
Calcium Hydroxide PP of primary molar teeth with deep carious lesions is used in studies conducted by Schroder and Trairatvorakul. Schroder. showed that the clinical-radiographic success rate of primary molar teeth one year after PP was 83 percent; they concluded that PP has the same favorable outcome as cervical formocresol pulpotomy (FP).
If the pulp is diagnosed as normal or as having reversible pulpitis, a new regenerative material is recommended as the dressing material. In comparison with complete pulpotomy (i.e., removal of the entire pulp chamber), PP has several advantages; it causes limited injury to the pulp and limited loss of tooth substances, and this is important for pulpal healing and easier restoration.
Pulpotomy is the pulp treatment most commonly used for primary teeth with a deep carious lesion approaching the pulp. With pulpotomy, a portion of the pulp is removed: the coronal pulp is removed and the radicular pulp is preserved. After treatment, the cavity is filled with a medicament followed by a final restoration.
Formocresol pulpotomy (FCP) was developed in 1932 by Charles A. Sweet.". The original FCP was a three-appointment procedure which has been reduced to a one-appointment procedure; it is still the most common treatment for primary teeth with caries approaching the pulp.
Studies have shown formocresol therapy to have a success rate between 70% and 90%.Histologic results have been variable in contrast to the high clinical success rate. Formocresol is still considered a gold standard by which all new modalities are compared.
MTA is used in pulp capping whether indirect or directly it has the advantage of biocompatibility to the pulp tissues and stimulates the odontoblast for thicker secondary dentine formation without tunnel defects and formation of hydroxyapatite like material to seal the pulp tissues. Although it has slow setting time, discolor the tooth, relatively high cost compared to the gold stander calcium hydroxide.
TheraCal light Cured (LC) is a single paste calcium silicate-based material promoted by the manufacturer for use as a pulp capping agent and as a protective liner for use with restorative materials, cement, or other base materials. The material might be very likable for clinicians because of its ease of handling. According to Alberto Danga in 2009 the cytotoxic effect of resin-based light-cured (Theracal) on human pulp tissue was least when compared to other materials.
There is a lack of evidence in partial pulpotomy treating primary teeth. In this study a Randomized control trial will be performed to have an evidence based answer for treating primary teeth with partial pulpotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| formocresol pulpotomy | Experimental | Drug: Formocresol, Procedure: pulpotomygold standard arm which pulpotomy will be done with formocresol |
| formocresol partial pulpotomy | Active comparator | Drug: Formocresol, Procedure: partial pulpotomypartial pulpotomy will be done with formocresol |
| MTA pulpotomy | Active comparator | Drug: MTA, Procedure: pulpotomyin this group complete pulpotomy will be done with MTA |
| MTA partial pulpotomy | Active comparator | Drug: MTA, Procedure: partial pulpotomyin this study group partial pulpotomy will be done with MTA |
| pulpotomy with Theracal LC | Active comparator | Drug: TheraCal, Procedure: pulpotomyin this study group complete pulpotomy will be done with Theracal LC |
| partial pulpotomy with Theracal LC | Active comparator | Drug: TheraCal, Procedure: partial pulpotomyin this study group partial pulpotomy technique will be done with Theracal LC |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- No history of spontaneous or nocturnal pain.
- History of transient pain of sensitivity resulting from various stimuli: hot, cold and sweets.
- Patient who had a bilateral deep carious lesion at second primary molars.
- absence of tenderness to percussion
- absence of physiologic or pathologic tooth mobility
Key exclusion criteria (6 listed)
- history of spontaneous or nocturnal pain.
- Patient who had a unilateral deep carious lesion.
- presence of tenderness to percussion
- presence of physiologic or pathologic tooth mobility
- Radiographic evidence of internal or external resorption.
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 |
|---|---|---|
| Formocresolmixture of formalin, cresol and glycerine used for fixation of pulp tissues | Drug | formocresol partial pulpotomy, formocresol pulpotomy |
| MTAAlso: Mineral trioxide aggregatematerial used for pulp regeneration, direct and indirect pulp capping | Drug | MTA partial pulpotomy, MTA pulpotomy |
| TheraCallight cured resin modified calcium silicate filled liner designed for use in direct and indirect pulp capping | Drug | partial pulpotomy with Theracal LC, pulpotomy with Theracal LC |
| pulpotomyremoval of the carious tooth structure and unroofing of the pulp chamber with a round carbide bur with high speed and water spray. The coronal pulp tissue will be then removed using a #4 carbide bur with slow speed and sharp spoon excavator. | Procedure or surgery | MTA pulpotomy, formocresol pulpotomy, pulpotomy with Theracal LC |
| partial pulpotomycomplete removal of caries till exposure occurs. The exposed surface of the pulp will be gently removed using a sterile round diamond bur and a high-speed, water-cooled handpiece with light hand pressure. The removal of the pulp did not exceed approximately two mm. | Procedure or surgery | MTA partial pulpotomy, formocresol partial pulpotomy, partial pulpotomy with Theracal LC |
Primary outcome
post operative pain
Time frame: 15 months
numerical/visual analogue scale 0 no pain 10 worst possible pain
7 secondary outcomes
radiolucency
Time frame: 15 months
fistula
Time frame: 15 months
tooth mobility
Time frame: 15 months
tenderness
Time frame: 15 months
root resorption
Time frame: 15 months
widening in periodontal ligament space
Time frame: 15 months
permanent tooth crypt involvement
Time frame: 15 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 18 Jan 2022.
- Results publication: PubMed 27377108Smail-Faugeron V, Porot A, Muller-Bolla M, Courson F. Indirect pulp capping versus pulpotomy for treating deep carious lesions approaching the pulp in primary teeth: a systematic review. Eur J Paediatr Dent. 2016 Jun;17(2):107-12.
- Results publication: PubMed 23550521Katz CR, de Andrade Mdo R, Lira SS, Ramos Vieira EL, Heimer MV. The concepts of minimally invasive dentistry and its impact on clinical practice: a survey with a group of Brazilian professionals. Int Dent J. 2013 Apr;63(2):85-90. doi: 10.1111/idj.12018. Epub 2013 Mar 12.
- Results publication: PubMed 29070150Dhar V, Marghalani AA, Crystal YO, Kumar A, Ritwik P, Tulunoglu O, Graham L. Use of Vital Pulp Therapies in Primary Teeth with Deep Caries Lesions. Pediatr Dent. 2017 Sep 15;39(5):146-159.
- Results publication: PubMed 6957533Cvek M, Cleaton-Jones PE, Austin JC, Andreasen JO. Pulp reactions to exposure after experimental crown fractures or grinding in adult monkeys. J Endod. 1982 Sep;8(9):391-7. doi: 10.1016/S0099-2399(82)80092-7. No abstract available.
- Results publication: PubMed 3481571Schroder U, Szpringer-Nodzak M, Janicha J, Wacinska M, Budny J, Mlosek K. A one-year follow-up of partial pulpotomy and calcium hydroxide capping in primary molars. Endod Dent Traumatol. 1987 Dec;3(6):304-6. doi: 10.1111/j.1600-9657.1987.tb00639.x. No abstract available.
- Results publication: PubMed 28836288Parirokh M, Torabinejad M, Dummer PMH. Mineral trioxide aggregate and other bioactive endodontic cements: an updated overview - part I: vital pulp therapy. Int Endod J. 2018 Feb;51(2):177-205. doi: 10.1111/iej.12841. Epub 2017 Sep 21.
- Results publication: PubMed 18565375Camp JH. Diagnosis dilemmas in vital pulp therapy: treatment for the toothache is changing, especially in young, immature teeth. J Endod. 2008 Jul;34(7 Suppl):S6-12. doi: 10.1016/j.joen.2008.03.020.
- Results publication: PubMed 28206897Wunsch PB, Kuhnen MM, Best AM, Brickhouse TH. Retrospective Study of the Survival Rates of Indirect Pulp Therapy Versus Different Pulpotomy Medicaments. Pediatr Dent. 2016 Oct 15;38(5):406-411.
- Results publication: PubMed 25872627George V, Janardhanan SK, Varma B, Kumaran P, Xavier AM. Clinical and radiographic evaluation of indirect pulp treatment with MTA and calcium hydroxide in primary teeth (in-vivo study). J Indian Soc Pedod Prev Dent. 2015 Apr-Jun;33(2):104-10. doi: 10.4103/0970-4388.155118.
- Results publication: PubMed 27175451El Meligy OA, Allazzam S, Alamoudi NM. Comparison between biodentine and formocresol for pulpotomy of primary teeth: A randomized clinical trial. Quintessence Int. 2016;47(7):571-80. doi: 10.3290/j.qi.a36095.
- Results publication: PubMed 24959601Poggio C, Arciola CR, Beltrami R, Monaco A, Dagna A, Lombardini M, Visai L. Cytocompatibility and antibacterial properties of capping materials. ScientificWorldJournal. 2014;2014:181945. doi: 10.1155/2014/181945. Epub 2014 May 18.
- Individual participant dataSharing planned: Yes. planning to publish my paper on pediatric dental journals
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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 Phase 4 study testing Formocresol, MTA and TheraCal in people with Decayed Primary Molars, run by Mansoura 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 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
post operative pain (time frame: 15 months). 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 NCT05190783, which also lists 11 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 18 Jan 2022.