An interventional study of Pulpotomy using Chitosan liquid and Pulpotomy using Formocresol in Pulpitis - Reversible and Pulpotomy, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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:
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.
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):
Group I (Experimental group) pulpotomy using chitosan liquid:
Group II (Control group) pulpotomy using formocresol:
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.
Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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.
Procedure: Pulpotomy using Chitosan liquid
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.
Procedure: Pulpotomy using Formocresol
1. 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.
Also known as: Chitosan Pulpotomy
1. 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.
Also known as: Formocresol Pulpotomy
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 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and 12 months
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 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 months
Plan to share: No
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Start is estimated for Apr 2025; primary completion for Jul 2025, 3 months later.
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