Comparison of Hyaluronic Acid, TheraCal, and Mineral Trioxide Aggregate as Pulpotomy Agents in Primary Molars
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorAl-Azhar University
About this trial
This randomized clinical trial aims to evaluation the clinical and radiographic outcomes of hyaluronic acid, TheraCal, and Mineral Trioxide Aggregate (MTA) when used as pulpotomy agents in primary molars.
The main question it aims to answer is:
In children with restorable mandibular second primary molars requiring pulpotomy, does the use of hyaluronic acid or TheraCal LC, compared to MTA, result in improved clinical and radiographic success rates over a 12-month follow-up period?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 4-8 years,
Co-operative patient
At least one restorable mandibular second primary molars with deep carious lesions requiring pulpotomy.
Absence of gingival swelling or sinus tract.
Disqualifiers
Swelling, sinus tract, or fistula.
Spontaneous pain.
Necrotic pulp, pathological mobility.
Cases require for general anesthesia.
Trial design
Design model
Parallel
Treatments tested in this trial
Hyaluronic Acid (HA)
Procedure/Surgery• After achieving complete hemostasis: 1. Mix HA (0,5% gengigel teething) with ZO powder until a mixture, then apply it on pulp stumps. 2. all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India)
TheraCal
Procedure/Surgery• After achieving complete hemostasis: 1. TheraCal L.C will be applied directly to the radicular pulp by a disposable syringe tip and light cure will be done for 20 seconds. 2. all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India)
Mineral Trioxide Aggregate
Procedure/Surgery• After achieving complete hemostasis: 1. mix MTA with sterile saline and put on pulp stumps. A moist cotton pellet was placed for initial setting. 2. all teeth will be restored with glass ionomer (Prevest Denpro Micron Superior Limited, India),then a stainless steel crown (3M, ESPE, USA) to ensure proper coronal seal and long-term success, which was cemented by glass ionomer cement(Prevest Denpro Micron Luting Limited, India)
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Hyaluronic acidExperimental treatment 1 intervention
Group B: TheraCalExperimental treatment 1 intervention
Group C: Mineral Trioxide AggregateActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical evaluation
Clinical evaluation: Absence of * Pain * Soft tissue swelling * Sinus tract * tenderness to percussion * tooth mobility
Time frame
3, 6, and 12 months.2
Radiographic evaluation
Conventional radiographic evaluation: absence of * Internal resorption. * External resorption. * Periapical or furcation RL. * Obliteration pulp calcification. * Widening of periodontal space.
Time frame
3, 6, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: