Pulpitis - ReversibleNCT06809478
Clinical and Radiographic Evaluation of Chitosan Versus Formocresol After Vital Pulpotomy of Primary Molars
A study testing Pulpotomy using Chitosan liquid and Pulpotomy using Formocresol in people with Pulpitis - Reversible and Pulpotomy, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate whether Chitosan liquid will show similar clinical and radiographical success rate compared to Formocresol when used in vital pulp therapy in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Reversible, Pulpotomy
- What is being tested?
- Pulpotomy using Chitosan liquid and Pulpotomy using Formocresol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy cooperative children with at least one deep carious mandibular primary molar indicated for vital pulpotomy.
- In age range from 4 to 8 years old.
- Both sexes will be included.
- Patients with provoked pain.
- Restorable teeth.
Who cannot join
- Excessive haemorrhage that cannot be stopped by a damp cotton pellet after several minutes.
- With congenital anomalies in teeth e.g., taurodontism, concrescence or fusion.
- Patients who show allergic reaction to any material will be used in this trial.
- Will not be able to stick to follow up protocol in the trial and refuse to give communication data.
- Patient's guardians refuse to sign up an informed consent before participating in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Radiographic Evaluation of Chitosan Versus Formocresol After Vital Pulpotomy of Primary Molars: a Randomized Clinical Study
The goal of this clinical trial is to evaluate whether Chitosan liquid will show similar clinical and radiographical success rate compared to Formocresol when used in vital pulp therapy in primary molars.
The main question it aims to answer is:
Read more
- Will Chitosan liquid, in comparison to Formocresol, show similar clinical outcomes in relation to presence/absence of post-operative pain, swelling, sinus and/or fistula formation when used in vital pulpotomy in primary molars?
- Will Chitosan liquid, in comparison to Formocresol, show similar radiographical outcomes in relation to presence/absence of furcal involvement, periapical lesion, pathological root resorption and/or widening of periodontal membrane space when used in vital pulpotomy in primary molars?
Following conventional pulpotomy procedure, the primary investigator will evaluate the effect of placing a cotton pellet damp with Chitosan liquid directly on radicular vital pulp compared to that of placing a cotton pellet damp with Formocresol on radicular vital pulp.
Primary teeth included in both arms of the study will be restored by zinc oxide and eugenol and covered by a stainless steel crown as final restoration.
The clinical trail will be followed up for 1 year. Clinical outcomes will be evaluated every 3 months. Radiographic outcomes will be evaluated every 6 months.
Read the detailed description
The main goal of pulp therapy is to maintain the integrity and health of the teeth and their supporting tissues while ensuring the vitality of the pulp of a tooth affected by caries, traumatic injury, or other causes.
Formocresol is a favored medicament for pulp therapy due to its proven success as a fixative, disinfectant, and devitalizing agent. For the past 70 years, it has been the most popular agent for vital pulpotomy in deciduous teeth with a success rate between 70-98%. However, concerns were issued about the potential toxic, mutagenic and cytotoxic effects of formocresol use.
Chitosan is a polysaccharide obtained by alkaline de-acetylation of chitin which is a very common natural biopolymer that can be found in the exoskeleton of crustacea. Chitosan is extensively studied in medical and pharmaceutical fields due to its competitive biological properties like biocompatibility, nontoxicity, analgesic, antitumor, hemostatic, antimicrobial, and antioxidant effects that makes it very interesting to develop for application in dentistry
The aim of the study is to evaluate the clinical and radiographical efficacy of chitosan liquid as pulp medicament compared to formocresol in vital pulpotomy of lower deciduous molars.
In this clinical trial, the principal investigator will carry out all treatment procedures, and the patients will be randomly assigned to any of the intervention groups. For both interventions, informed consent will be obtained from parents/guardians of the participating children.
For both interventions (1 experimental arm group and 1 active comparator arm group):
- Diagnosis of the cases will be performed according to guidelines by the American Academy of Pediatric Dentistry for treatment of vital pulp therapy in primary teeth and a diagnostic chart with personal, medical and dental history will be filled.
- Clinical examination will be done in the dental clinic using mirror and probe to assess the clinical inclusion criteria.
- Preoperative periapical radiographs will be taken to assess the inclusion criteria. Preoperative radiograph will serve as a reference for the follow-up radiographs.
- Baseline records (personal data collection, photographs, percussion test and preoperative periapical radiographs) will be taken.
- An individual Extension Cone Paralleling index will be prepared for each patient by registering the bite through alginate impression and fabricating an acrylic radiographic stent from the patient's cast to allow consistent comparisons of the radiographs.
- Before starting intra-operative procedures, the tooth is allocated randomly (concealed by withdrawing a sealed opaque envelope containing four-folded numbered papers containing the type of dressing material that will be used then writing the patient's name and I.D. on it and will be opened after performing the access cavity).
- Apply topical anesthesia.
- Local anesthesia administration.
- Rubber dam application and access cavity preparation will be established using a sterile bur.
- The envelope marked by the patient's name and I.D. will be opened and the tooth will be allocated into either one of the groups alternatively depending on the pulpotomy medicament used either into Group I (Experimental group) or Group II (Control group)
Group I (Experimental group) pulpotomy using chitosan liquid:
- After complete hemostasis, a cotton pellet damp with chitosan liquid will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet.
- Tooth will be restored with stainless steel crown.
Group II (Control group) pulpotomy using formocresol:
- After complete hemostasis, a cotton pellet damp with formocresol will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet.
- Tooth will be restored with stainless steel crown.
The participants are recalled for clinical evaluation at the interval of 3, 6, 9, 12 months, and recalled for radiographic evaluation at 6 and 12 months.
- Conditions
- Pulpitis - Reversible, Pulpotomy
- Being tested
- Pulpotomy using Chitosan liquid, Pulpotomy using Formocresol
- Keywords
- pulpotomy, formocresol, chitosan, primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpotomy using Chitosan liquidProcedure or surgery
Also called Chitosan Pulpotomy
- After complete hemostasis, a cotton pellet damp with chitosan liquid will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet.
- Tooth will be restored with stainless steel crown.
Pulpotomy using FormocresolProcedure or surgery
Also called Formocresol Pulpotomy
- After complete hemostasis, a cotton pellet damp with formocresol will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet.
- Tooth will be restored with stainless steel crown.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy using Chitosan | Experimental | Chitosan is a natural cationic polysaccharide polymer obtained from chitin deacetylation. It is a linear biopolymer consisting of 2-amino-2-deoxy-β-D-glucose (60-100%) and 2-acetamino -2-deoxy-β-D-glucoside (0-50%) bound together by ß (1→4) bonds. It is biocompatible and has antibacterial, anti-inflammatory and hemostatic properties. Receives: Procedure: Pulpotomy using Chitosan liquid |
| Pulpotomy using Formocresol | Active comparator | Buckley's formocresol is composed of 31% water base, 15% glycerin to prevent formaldehyde from polymerizing to paraformaldehyde, 19% formaldehyde as an alkylating agent, and 35% tricresol as a protein-coagulating phenolic substance. A 1:5 concentration of Buckley's formocresol is used in this trial. Receives: Procedure: Pulpotomy using Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 3 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 3 months
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 6 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 6 months
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 9 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 9 months
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 12 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 12 months
Secondary outcomes (16)
Change from Baseline in regards to swelling at 3 months
Visual examination for any sign of redness or swelling of the gingiva at that time frame and clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 3 months
Change from Baseline in regards to swelling at 6 months
Visual examination for any sign of redness or swelling of the gingiva at that time frame and clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 6 months
Change from Baseline in regards to swelling at 9 months
Visual examination for any sign of redness or swelling of the gingiva at that time frame and clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 9 months
Change from Baseline in regards to swelling at 12 months
Visual examination for any sign of redness or swelling of the gingiva at that time frame and clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 12 months
Change from Baseline in regards to sinus or fistula at 3 months
Visual examination for any sign of a sinus or fistula in the gingiva at that time frame and clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 3 months
Change from Baseline in regards to sinus or fistula at 6 months
Visual examination for any sign of a sinus or fistula in the gingiva at that time frame and clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 6 months
Change from Baseline in regards to sinus or fistula at 9 months
Visual examination for any sign of a sinus or fistula in the gingiva at that time frame and clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 9 months
Change from Baseline in regards to sinus or fistula at 12 months
Visual examination for any sign of a sinus or fistula in the gingiva at that time frame and clinically. Outcome measuring unit: Binary (present/absent)
Measured: Baseline and 12 months
Change from Baseline in regards to furcal lesion at 6 months using Furcation Involvement Scores
Radiographic evaluation by visual interpretation of DIGORA software for any furcal lesion using Furcation Involvement Scores. Possible scores range from 0 (no radiolucency) ; 1 (radiolucency between ¼ of furcation to periapical areas); 2 (radiolucency between ¼ to ½ of furcation to periapical areas); 3 (radiolucency more than ½ of furcation to periapical areas).
Measured: Baseline and 6 months
Change from Baseline in regards to furcal lesion at 12 months using Furcation Involvement Scores
Radiographic evaluation by visual interpretation of DIGORA software for any furcal lesion using Furcation Involvement Scores. Possible scores range from 0 (no radiolucency) ; 1 (radiolucency between ¼ of furcation to periapical areas); 2 (radiolucency between ¼ to ½ of furcation to periapical areas); 3 (radiolucency more than ½ of furcation to periapical areas).
Measured: Baseline and 12 months
Change from Baseline in regards to periapical lesion at 6 months
Radiographic evaluation by visual interpretation of DIGORA software for any periapical lesion, cyst formation or obliteration.
Measured: Baseline and 6 months
Change from Baseline in regards to periapical lesion at 12 months
Radiographic evaluation by visual interpretation of DIGORA software for any periapical lesion, cyst formation or obliteration.
Measured: Baseline and 12 months
Change from Baseline in regards to pathologic root resorption at 6 months
Radiographic evaluation by visual interpretation of DIGORA software for any internal, external, early or pathologic root resorption from periapical radiographs.
Measured: Baseline and 6 months
Change from Baseline in regards to pathologic root resorption at 12 months
Radiographic evaluation by visual interpretation of DIGORA software for any internal, external, early or pathologic root resorption from periapical radiographs.
Measured: Baseline and 12 months
Change from Baseline in regards to width of periodontal membrane space at 6 months
Radiographic evaluation by visual interpretation of DIGORA software for any widening in periodontal membrane space from periapical radiographs.
Measured: Baseline and 6 months
Change from Baseline in regards to width of periodontal membrane space at 12 months
Radiographic evaluation by visual interpretation of DIGORA software for any widening in periodontal membrane space from periapical radiographs.
Measured: Baseline 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 posted5 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - ReversibleStudies 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, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Ibrahim Helmi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809478
- Sponsor's protocol ID
- CS Pulpotomy
- Status last verified
- Feb 2025
- First submitted
- 16 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Chitosan Versus Formocresol After Vital Pulpotomy of Primary Molars: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06809478
- Acronym / sponsor ID
- CS Pulpotomy
- Conditions
- Pulpitis - Reversible, Pulpotomy
- Keywords
- pulpotomy, formocresol, chitosan, primary molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Feb 2025 (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 goal of this clinical trial is to evaluate whether Chitosan liquid will show similar clinical and radiographical success rate compared to Formocresol when used in vital pulp therapy in primary molars.
The main question it aims to answer is:
- Will Chitosan liquid, in comparison to Formocresol, show similar clinical outcomes in relation to presence/absence of post-operative pain, swelling, sinus and/or fistula formation when used in vital pulpotomy in primary molars?
- Will Chitosan liquid, in comparison to Formocresol, show similar radiographical outcomes in relation to presence/absence of furcal involvement, periapical lesion, pathological root resorption and/or widening of periodontal membrane space when used in vital pulpotomy in primary molars?
Following conventional pulpotomy procedure, the primary investigator will evaluate the effect of placing a cotton pellet damp with Chitosan liquid directly on radicular vital pulp compared to that of placing a cotton pellet damp with Formocresol on radicular vital pulp.
Primary teeth included in both arms of the study will be restored by zinc oxide and eugenol and covered by a stainless steel crown as final restoration.
The clinical trail will be followed up for 1 year. Clinical outcomes will be evaluated every 3 months. Radiographic outcomes will be evaluated every 6 months.
Detailed description
The main goal of pulp therapy is to maintain the integrity and health of the teeth and their supporting tissues while ensuring the vitality of the pulp of a tooth affected by caries, traumatic injury, or other causes.
Formocresol is a favored medicament for pulp therapy due to its proven success as a fixative, disinfectant, and devitalizing agent. For the past 70 years, it has been the most popular agent for vital pulpotomy in deciduous teeth with a success rate between 70-98%. However, concerns were issued about the potential toxic, mutagenic and cytotoxic effects of formocresol use.
Chitosan is a polysaccharide obtained by alkaline de-acetylation of chitin which is a very common natural biopolymer that can be found in the exoskeleton of crustacea. Chitosan is extensively studied in medical and pharmaceutical fields due to its competitive biological properties like biocompatibility, nontoxicity, analgesic, antitumor, hemostatic, antimicrobial, and antioxidant effects that makes it very interesting to develop for application in dentistry
The aim of the study is to evaluate the clinical and radiographical efficacy of chitosan liquid as pulp medicament compared to formocresol in vital pulpotomy of lower deciduous molars.
In this clinical trial, the principal investigator will carry out all treatment procedures, and the patients will be randomly assigned to any of the intervention groups. For both interventions, informed consent will be obtained from parents/guardians of the participating children.
For both interventions (1 experimental arm group and 1 active comparator arm group):
- Diagnosis of the cases will be performed according to guidelines by the American Academy of Pediatric Dentistry for treatment of vital pulp therapy in primary teeth and a diagnostic chart with personal, medical and dental history will be filled.
- Clinical examination will be done in the dental clinic using mirror and probe to assess the clinical inclusion criteria.
- Preoperative periapical radiographs will be taken to assess the inclusion criteria. Preoperative radiograph will serve as a reference for the follow-up radiographs.
- Baseline records (personal data collection, photographs, percussion test and preoperative periapical radiographs) will be taken.
- An individual Extension Cone Paralleling index will be prepared for each patient by registering the bite through alginate impression and fabricating an acrylic radiographic stent from the patient's cast to allow consistent comparisons of the radiographs.
- Before starting intra-operative procedures, the tooth is allocated randomly (concealed by withdrawing a sealed opaque envelope containing four-folded numbered papers containing the type of dressing material that will be used then writing the patient's name and I.D. on it and will be opened after performing the access cavity).
- Apply topical anesthesia.
- Local anesthesia administration.
- Rubber dam application and access cavity preparation will be established using a sterile bur.
- The envelope marked by the patient's name and I.D. will be opened and the tooth will be allocated into either one of the groups alternatively depending on the pulpotomy medicament used either into Group I (Experimental group) or Group II (Control group)
Group I (Experimental group) pulpotomy using chitosan liquid:
- After complete hemostasis, a cotton pellet damp with chitosan liquid will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet.
- Tooth will be restored with stainless steel crown.
Group II (Control group) pulpotomy using formocresol:
- After complete hemostasis, a cotton pellet damp with formocresol will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet.
- Tooth will be restored with stainless steel crown.
The participants are recalled for clinical evaluation at the interval of 3, 6, 9, 12 months, and recalled for radiographic evaluation at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy using Chitosan | Experimental | Procedure: Pulpotomy using Chitosan liquidChitosan is a natural cationic polysaccharide polymer obtained from chitin deacetylation. It is a linear biopolymer consisting of 2-amino-2-deoxy-β-D-glucose (60-100%) and 2-acetamino -2-deoxy-β-D-glucoside (0-50%) bound together by ß (1→4) bonds. It is biocompatible and has antibacterial, anti-inflammatory and hemostatic properties. |
| Pulpotomy using Formocresol | Active comparator | Procedure: Pulpotomy using FormocresolBuckley's formocresol is composed of 31% water base, 15% glycerin to prevent formaldehyde from polymerizing to paraformaldehyde, 19% formaldehyde as an alkylating agent, and 35% tricresol as a protein-coagulating phenolic substance. A 1:5 concentration of Buckley's formocresol is used in this trial. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy cooperative children with at least one deep carious mandibular primary molar indicated for vital pulpotomy.
- In age range from 4 to 8 years old.
- Both sexes will be included.
- Patients with provoked pain.
- Restorable teeth.
Key exclusion criteria (5 listed)
- Excessive haemorrhage that cannot be stopped by a damp cotton pellet after several minutes.
- With congenital anomalies in teeth e.g., taurodontism, concrescence or fusion.
- Patients who show allergic reaction to any material will be used in this trial.
- Will not be able to stick to follow up protocol in the trial and refuse to give communication data.
- Patient's guardians refuse to sign up an informed consent before participating in this trial.
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 using Chitosan liquidAlso: Chitosan Pulpotomy1. After complete hemostasis, a cotton pellet damp with chitosan liquid will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet. 2. Tooth will be restored with stainless steel crown. | Procedure or surgery | Pulpotomy using Chitosan |
| Pulpotomy using FormocresolAlso: Formocresol Pulpotomy1. After complete hemostasis, a cotton pellet damp with formocresol will be applied and gently placed over the pulp stumps for 5 minutes and removed. Then, a thick mix of zinc oxide and eugenol will be placed and gently condensed into the pulp chamber by a moistened cotton pellet. 2. Tooth will be restored with stainless steel crown. | Procedure or surgery | Pulpotomy using Formocresol |
Primary outcome
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 3 months
Time frame: Baseline and 3 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 6 months
Time frame: Baseline and 6 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 9 months
Time frame: Baseline and 9 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 12 months
Time frame: Baseline and 12 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
16 secondary outcomes
Change from Baseline in regards to swelling at 3 months
Time frame: Baseline and 3 months
Change from Baseline in regards to swelling at 6 months
Time frame: Baseline and 6 months
Change from Baseline in regards to swelling at 9 months
Time frame: Baseline and 9 months
Change from Baseline in regards to swelling at 12 months
Time frame: Baseline and 12 months
Change from Baseline in regards to sinus or fistula at 3 months
Time frame: Baseline and 3 months
Change from Baseline in regards to sinus or fistula at 6 months
Time frame: Baseline and 6 months
Change from Baseline in regards to sinus or fistula at 9 months
Time frame: Baseline and 9 months
Change from Baseline in regards to sinus or fistula at 12 months
Time frame: Baseline and 12 months
Change from Baseline in regards to furcal lesion at 6 months using Furcation Involvement Scores
Time frame: Baseline and 6 months
Change from Baseline in regards to furcal lesion at 12 months using Furcation Involvement Scores
Time frame: Baseline and 12 months
Change from Baseline in regards to periapical lesion at 6 months
Time frame: Baseline and 6 months
Change from Baseline in regards to periapical lesion at 12 months
Time frame: Baseline and 12 months
Change from Baseline in regards to pathologic root resorption at 6 months
Time frame: Baseline and 6 months
Change from Baseline in regards to pathologic root resorption at 12 months
Time frame: Baseline and 12 months
Change from Baseline in regards to width of periodontal membrane space at 6 months
Time frame: Baseline and 6 months
Change from Baseline in regards to width of periodontal membrane space at 12 months
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- 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.
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 using Chitosan liquid and Pulpotomy using Formocresol in people with Pulpitis - Reversible and Pulpotomy, 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 5 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: opening soon, as of the sponsor's last update on 5 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reem I Helmi ((+20) 1151806686, reem.helmi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 3 months (time frame: Baseline and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.