Clinical and Radiographic Evaluation of Chitosan Versus Formocresol After Vital Pulpotomy of Primary Molars
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pulpotomy using Chitosan liquid
Procedure/Surgery1. 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.
Pulpotomy using Formocresol
Procedure/Surgery1. 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Pulpotomy using ChitosanExperimental treatment 1 intervention
Group B: Pulpotomy using FormocresolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline and 3 months2
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)
Time frame
Baseline and 6 months3
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)
Time frame
Baseline and 9 months4
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)
Time frame
Baseline and 12 monthsSecondary outcomes
1
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)
Time frame
Baseline and 3 months2
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)
Time frame
Baseline and 6 months3
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)
Time frame
Baseline and 9 months4
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)
Time frame
Baseline and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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