Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars
- Conditions
- Pulpotomies Primary TeethPulp Disease, Dental
- Interventions
- Procedure: Hyaluronic acid pulpotomyProcedure: mineral trioxide aggregate pulpotomy
- Registration Number
- NCT06611631
- Lead Sponsor
- Cairo University
- Brief Summary
The goal of this clinical trial is to Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars.
The main question it aims to answer is:
Is there a difference in the clinical or radiographic success when using Hyaluronic acid (Gengigel Teething, Ricerfarma , Italy) versus mineral trioxide aggregate (Angelus, Londrina ,Brazil) in pulpotomy of carious primary molars in children?
- Detailed Description
Preservation of primary dentition decreases the risk of developing any occlusal abnormalities caused by premature loss of primary teeth, which are considered natural space maintainers for the successor permanent teeth, therefore vital pulp therapy is of a big concern in the research field in pediatric dentistry.
One of the most commonly used regenerative materials in pulpotomies is Mineral Trioxide Aggregate (MTA) which showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability . However it has some drawbacks such as difficult manipulation and handling because it is supplied in powder and liquid form which need mixing. Mixing is operator dependent and may be not uniform if handled wrongly, technique sensitive, potential discoloration, and long setting time.
Hyaluronic acid have been introduced as a new biologically based therapeutics directed at preserving pulp vitality. Owing to good handling characteristics, biocompatibility, odontogenic property. non-toxic, biodegradable ,non-immunogenic , anti-inflammatory and antibacterial action, hyaluronic acid is a promising pulpotomy agent Furthermore, the use of a gel containing HA facilitated faster healing in laser-induced wounds by secondary intention. HA tends to be helpful in the treatment of swelling and trismus as well as the inflammatory reaction after third molar extraction.
The benefits of this study to the participants:
A cheaper , faster and easier clinical procedure leads to a more efficient dental treatment, which could develop positive attitude of children towards dentistry.
The benefits of this study to the population:
1. Providing better quality of dental treatment.
2. Enhance the overall oral health of children.
The benefits of this study to the clinicians:
1. Providing a new biological and alternative treatment option.
2. Decreased chairside time owing to its better manipulation and less technique sensitive .
3. cheaper and accessible alternative .
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 34
- Patients:
Aged 4-8 years, in good general health and medically within normal.
Teeth:
- Restorable mandibular primary molars.
- History of reversible pulpitis.
Pre-operative Radiographic criteria:
- Absence of periapical or inter-radicular radiolucencies.
- Absence of widening of periodontal ligaments (PDL) space.
- Absence of internal or external root resorption.
Patients:
- With systemic disorders.
- Physical or mental disabilities.
- Unable to attend follow- up visits.
- Refusal of Participation.
- Refusal to sign the informed consent.
Teeth:
- Previously accessed teeth.
- Mobile mandibular primary molars.
- Swelling in the vestibule or on palpation.
- Pain on percussion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hyaluronic Acid Pulpotmoy Hyaluronic acid pulpotomy 1. After complete hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder to reach suitable consistency (1:1 ratio by volume) then gentle condensation in the pulp chamber will be done by a moistened cotton pellet and then the rest of the pulp chamber will be filled by glass ionomer restoration . 2. Tooth will be restored with stainless steel crown. Mineral Trioxide Aggregate mineral trioxide aggregate pulpotomy 1. After complete hemostasis, MTA+ saline will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of glass ionomer restoration. 2. Tooth will then be restored with stainless steel crown.
- Primary Outcome Measures
Name Time Method Absence of post- operative pain. 1 week changes from baseline pulp condition Asking the patient and/or guardian. Outcome measuring unit :Binary (present/absent)
Absence of pain on percussion. at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month. Percussion test using the back of a dental mirror. Outcome measuring unit :Binary (present/absent)
Absence of Swelling. at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month. Visual examination. Outcome measuring unit :Binary (present/absent)
Absence of Sinus or fistula. at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month. Visual examination. Outcome measuring unit :Binary (present/absent)
Pathologic mobility at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month. Mobility test (pressure using the end of two dental mirrors). Outcome measuring unit :Binary (present/absent)
- Secondary Outcome Measures
Name Time Method Absence of furcation or periapical radiolucency. at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month. Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Absence of any adverse radiographic finding. at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month. Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Absence of external or internal root resorption. at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month. Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Trial Locations
- Locations (1)
Cairo University
🇪🇬Cairo, Egypt