PulpotomiesNCT04634123
The Use of Portland Cement in Primary Anterior Teeth Pulpotomy.
A study testing Pulpotomy therapy by White Portland Cement and Pulpotomy therapy by White MTA in people with Pulpotomies, run by Damascus University at 1 site in Syria.
Trial summary
The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in primary anterior teeth pulpotomy and follow up after 3 , 6 , 12 months ( Clinically and Radiographically) : Group A ( Control group ) : primary anterior teeth pulpotomized by White MTA . Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Pulpotomies
- What is being tested?
- Pulpotomy therapy by White Portland Cement and Pulpotomy therapy by White MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSyria
- Study dates
- 1 Apr 2020to 1 Jul 2021
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 4 and 9 years.
- Definitely positive or positive ratings of Frank scale.
- Caries include maximum two surfaces
- Pulp exposure during caries removal
- Pulpal hemorrhage light red acceptable to hemostasis
- Physiological root resorption no more than the apical third
- Absence clinical and radiographic signs which indicate pulp necrosis
Who cannot join
- Systematic or mental disorders.
- Definitely negative or negative ratings of Frankel scale
- Existence periapical translucence
- Existence external or internal abnormal absorption
- Existence swelling or fistula
- Sensitivity to percussion
- Existence of spontaneous or stimulant pain
- Excessive movement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Using of White Portland Cement and MTA in Pulpotomy Primary Anterior Teeth
- The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in primary anterior teeth pulpotomy and follow up after 3 , 6 , 12 months ( Clinically and Radiographically) : Group A ( Control group ) : primary anterior teeth pulpotomized by White MTA . Group B : primary anterior teeth pulpotomized by White Portland Cement .
- The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in pulpotomy primary canines for serial extraction and extract them after 3 months for Histopathlogic study : Group A ( Control group ) : primary canines pulpotomized by White MTA . Group B : primary canines pulpotomized by White Portland Cement .
Read the detailed description
- Endodontic therapy for primary teeth faces several difficulties including morphology of root canals , physiological root absorption and failure to find ideal root-filling paste absorbs the same degree of root absorption .
- Pulpotomy therapy is considered easy , fast and does not include the length of canal or periapical region .
- The split mouth design will be adopted for the treated samples .
- Clinical success criteria :
- Absence of spontaneous or stimulant pain
- Absence gingival redness , swelling or fistula
- Physiological tooth mobility and absence sensitivity to percussion
- Radiographically success criteria :
- Absence periapical translucence
- Absence external or internal abnormal absorption
- Conditions
- Pulpotomies
- Being tested
- Pulpotomy therapy by White Portland Cement, Pulpotomy therapy by White MTA
- Keywords
- Pulpotomy, Portland cement, Primary Anterior Teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpotomy therapy by White Portland CementOther
Carious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined using a sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White Portland Cement
Pulpotomy therapy by White MTAOther
Carious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined usinga sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White MTA
| Study group | Role | What they receive |
|---|---|---|
| Primary anterior teeth pulpotomy by White Portland Cement | Experimental | Not described Receives: Other: Pulpotomy therapy by White Portland Cement |
| Primary anterior teeth pulpotomy by White MTA | Other | Not described Receives: Other: Pulpotomy therapy by White MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of White Portland Cement pulpotomies 3 months after treatment
Clinical evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Measured: 3 months
Clinical evaluation of White Portland Cement pulpotomies 6 months after treatment
Clinical evaluation of White Portland Cement pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Measured: 6 months
Clinical evaluation of White Portland Cement pulpotomies 12 months after treatment
Clinical evaluation of White Portland Cement pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Measured: 12 months
Clinical evaluation of White MTA pulpotomies 3 months after treatment
Clinical evaluation of White MTA pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Measured: 3 months
Clinical evaluation of White MTA pulpotomies 6 months after treatment
Clinical evaluation of White MTA pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Measured: 6 months
Clinical evaluation of White MTA pulpotomies 12 months after treatment
Clinical evaluation of White MTA pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Measured: 12 months
Radiographic evaluation of White Portland Cement pulpotomies 3 months after treatment
Radiographic evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Measured: 3 months
Radiographic evaluation of White Portland Cement pulpotomies 6 months after treatment
Radiographic evaluation of White Portland Cement pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Measured: 6 months
Radiographic evaluation of White Portland Cement pulpotomies 12 months after treatment
Radiographic evaluation of White Portland Cement pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Measured: 12 months
Radiographic evaluation of White MTA pulpotomies 3 months after treatment
Radiographic evaluation of White MTAt pulpotomies was performed 3 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Measured: 3 months
Radiographic evaluation of White MTA pulpotomies 6 months after treatment
Radiographic evaluation of White MTAt pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Measured: 6 months
Radiographic evaluation of White MTA pulpotomies 12 months after treatment
Radiographic evaluation of White MTAt pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Measured: 12 months
Histopathlogic evaluation of White Portland Cement 3 months after treatment
Histopathlogical evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using the preset histopathlogical criteria. The pulpotomy procedure was decided a histopathlogical success if the tooth fulfilled the following criteria: (1) Normal soft tissue, (2) Formulation dentin bridge, (3) Normal bleeding from pulp tissue, (4) No fibrosis, and (5) No pulp calcification
Measured: 3 months
Histopathlogic evaluation of White MTA 3 months after treatment
Histopathlogical evaluation of White MTA pulpotomies was performed 3 months after treatment using the preset histopathlogical criteria. The pulpotomy procedure was decided a histopathlogical success if the tooth fulfilled the following criteria: (1) Normal soft tissue, (2) Formulation dentin bridge, (3) Normal bleeding from pulp tissue, (4) No fibrosis, and (5) No pulp calcification
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Apr 2020
- Primary completion30 Nov 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PulpotomiesStudies 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
- Crossover
- Model description
- Split mouth design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hasan M Alzoubi, DDs, Principal investigator, MSc student in Pedodontics, University of DamascusNada G Bshara, Phd, Study director, Professor of Pedodontics, Department of Pedodontics, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634123
- Sponsor's protocol ID
- UDDS-Pedo-02-2021
- Status last verified
- Nov 2021
- First submitted
- 31 Jan 2020
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen TD, Judd PL, Barrett EJ, Sidhu N, Casas MJ. Comparison of Ferric Sulfate Combined Mineral Trioxide Aggregate Pulpotomy and Zinc Oxide Eugenol Pulpectomy of Primary Maxillary Incisors: An 18-month Randomized, Controlled Trial. Pediatr Dent. 2017 Jan 15;39(1):34-38.
PubMed 28292339Aminabadi NA, Farahani RM, Gajan EB. A clinical study of formocresol pulpotomy versus root canal therapy of vital primary incisors. J Clin Pediatr Dent. 2008 Spring;32(3):211-4. doi: 10.17796/jcpd.32.3.ghk26v4554790074.
PubMed 18524271Casas MJ, Kenny DJ, Johnston DH, Judd PL, Layug MA. Outcomes of vital primary incisor ferric sulfate pulpotomy and root canal therapy. J Can Dent Assoc. 2004 Jan;70(1):34-8.
PubMed 14709254Howley B, Seale NS, McWhorter AG, Kerins C, Boozer KB, Lindsey D. Pulpotomy versus pulpectomy for carious vital primary incisors: randomized controlled trial. Pediatr Dent. 2012 Sep-Oct;34(5):112-9.
PubMed 23211895Islam I, Chng HK, Yap AU. Comparison of the root-end sealing ability of MTA and Portland cement. Aust Endod J. 2005 Aug;31(2):59-62. doi: 10.1111/j.1747-4477.2005.tb00223.x.
PubMed 16128253
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Using of White Portland Cement and MTA in Pulpotomy Primary Anterior Teeth
- ClinicalTrials.gov ID
- NCT04634123
- Acronym / sponsor ID
- UDDS-Pedo-02-2021
- Conditions
- Pulpotomies
- Keywords
- Pulpotomy, Portland cement, Primary Anterior Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in primary anterior teeth pulpotomy and follow up after 3 , 6 , 12 months ( Clinically and Radiographically) : Group A ( Control group ) : primary anterior teeth pulpotomized by White MTA . Group B : primary anterior teeth pulpotomized by White Portland Cement .
- The aim of this study is to evaluate the effectiveness of White Portland cement and MTA in pulpotomy primary canines for serial extraction and extract them after 3 months for Histopathlogic study : Group A ( Control group ) : primary canines pulpotomized by White MTA . Group B : primary canines pulpotomized by White Portland Cement .
Detailed description
- Endodontic therapy for primary teeth faces several difficulties including morphology of root canals , physiological root absorption and failure to find ideal root-filling paste absorbs the same degree of root absorption .
- Pulpotomy therapy is considered easy , fast and does not include the length of canal or periapical region .
- The split mouth design will be adopted for the treated samples .
- Clinical success criteria :
- Absence of spontaneous or stimulant pain
- Absence gingival redness , swelling or fistula
- Physiological tooth mobility and absence sensitivity to percussion
- Radiographically success criteria :
- Absence periapical translucence
- Absence external or internal abnormal absorption
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth design
| Arm | Type | Receives |
|---|---|---|
| Primary anterior teeth pulpotomy by White Portland Cement | Experimental | Other: Pulpotomy therapy by White Portland Cement |
| Primary anterior teeth pulpotomy by White MTA | Other | Other: Pulpotomy therapy by White MTA |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age between 4 and 9 years.
- Definitely positive or positive ratings of Frank scale.
- Caries include maximum two surfaces
- Pulp exposure during caries removal
- Pulpal hemorrhage light red acceptable to hemostasis
Key exclusion criteria (8 listed)
- Systematic or mental disorders.
- Definitely negative or negative ratings of Frankel scale
- Existence periapical translucence
- Existence external or internal abnormal absorption
- Existence swelling or fistula
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 |
|---|---|---|
| Pulpotomy therapy by White Portland CementCarious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined using a sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White Portland Cement | Other | Primary anterior teeth pulpotomy by White Portland Cement |
| Pulpotomy therapy by White MTACarious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined usinga sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White MTA | Other | Primary anterior teeth pulpotomy by White MTA |
Primary outcome
Clinical evaluation of White Portland Cement pulpotomies 3 months after treatment
Time frame: 3 months
Clinical evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Clinical evaluation of White Portland Cement pulpotomies 6 months after treatment
Time frame: 6 months
Clinical evaluation of White Portland Cement pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Clinical evaluation of White Portland Cement pulpotomies 12 months after treatment
Time frame: 12 months
Clinical evaluation of White Portland Cement pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Clinical evaluation of White MTA pulpotomies 3 months after treatment
Time frame: 3 months
Clinical evaluation of White MTA pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Clinical evaluation of White MTA pulpotomies 6 months after treatment
Time frame: 6 months
Clinical evaluation of White MTA pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Clinical evaluation of White MTA pulpotomies 12 months after treatment
Time frame: 12 months
Clinical evaluation of White MTA pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility
Radiographic evaluation of White Portland Cement pulpotomies 3 months after treatment
Time frame: 3 months
Radiographic evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Radiographic evaluation of White Portland Cement pulpotomies 6 months after treatment
Time frame: 6 months
Radiographic evaluation of White Portland Cement pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Radiographic evaluation of White Portland Cement pulpotomies 12 months after treatment
Time frame: 12 months
Radiographic evaluation of White Portland Cement pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Radiographic evaluation of White MTA pulpotomies 3 months after treatment
Time frame: 3 months
Radiographic evaluation of White MTAt pulpotomies was performed 3 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Radiographic evaluation of White MTA pulpotomies 6 months after treatment
Time frame: 6 months
Radiographic evaluation of White MTAt pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Radiographic evaluation of White MTA pulpotomies 12 months after treatment
Time frame: 12 months
Radiographic evaluation of White MTAt pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure
Histopathlogic evaluation of White Portland Cement 3 months after treatment
Time frame: 3 months
Histopathlogical evaluation of White Portland Cement pulpotomies was performed 3 months after treatment using the preset histopathlogical criteria. The pulpotomy procedure was decided a histopathlogical success if the tooth fulfilled the following criteria: (1) Normal soft tissue, (2) Formulation dentin bridge, (3) Normal bleeding from pulp tissue, (4) No fibrosis, and (5) No pulp calcification
Histopathlogic evaluation of White MTA 3 months after treatment
Time frame: 3 months
Histopathlogical evaluation of White MTA pulpotomies was performed 3 months after treatment using the preset histopathlogical criteria. The pulpotomy procedure was decided a histopathlogical success if the tooth fulfilled the following criteria: (1) Normal soft tissue, (2) Formulation dentin bridge, (3) Normal bleeding from pulp tissue, (4) No fibrosis, and (5) No pulp calcification
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 9 Dec 2021.
- Background: PubMed 28292339Nguyen TD, Judd PL, Barrett EJ, Sidhu N, Casas MJ. Comparison of Ferric Sulfate Combined Mineral Trioxide Aggregate Pulpotomy and Zinc Oxide Eugenol Pulpectomy of Primary Maxillary Incisors: An 18-month Randomized, Controlled Trial. Pediatr Dent. 2017 Jan 15;39(1):34-38.
- Background: PubMed 18524271Aminabadi NA, Farahani RM, Gajan EB. A clinical study of formocresol pulpotomy versus root canal therapy of vital primary incisors. J Clin Pediatr Dent. 2008 Spring;32(3):211-4. doi: 10.17796/jcpd.32.3.ghk26v4554790074.
- Background: PubMed 14709254Casas MJ, Kenny DJ, Johnston DH, Judd PL, Layug MA. Outcomes of vital primary incisor ferric sulfate pulpotomy and root canal therapy. J Can Dent Assoc. 2004 Jan;70(1):34-8.
- Background: PubMed 23211895Howley B, Seale NS, McWhorter AG, Kerins C, Boozer KB, Lindsey D. Pulpotomy versus pulpectomy for carious vital primary incisors: randomized controlled trial. Pediatr Dent. 2012 Sep-Oct;34(5):112-9.
- Background: PubMed 16128253Islam I, Chng HK, Yap AU. Comparison of the root-end sealing ability of MTA and Portland cement. Aust Endod J. 2005 Aug;31(2):59-62. doi: 10.1111/j.1747-4477.2005.tb00223.x.
- Individual participant dataSharing planned: No
Related trials for Pulpotomies
Recruiting
Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis (SIP)
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
Not yet recruiting
Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate)
Periapical Healing
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
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.
Hasan M Alzoubi, DDs principal investigator
MSc student in Pedodontics, University of Damascus
Nada G Bshara, Phd study director
Professor of Pedodontics, Department of Pedodontics, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy therapy by White Portland Cement and Pulpotomy therapy by White MTA in people with Pulpotomies, run by Damascus University at 1 site in Syria.
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 8 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 9 Dec 2021. 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 Syria. 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 evaluation of White Portland Cement pulpotomies 3 months after treatment (time frame: 3 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04634123, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.