Comparative evaluation of clinical and radiographic outcome of MTA, THERACAL LC, and 3MIXTATIN as indirect pulp capping material in primary teeth: A Randomized Clinical Trial

PRIMARY OBJECTIVE: To evaluate and compare the clinical and radiographic outcome of MTA, TheraCal LC and 3Mixtatin as Indirect pulp capping materials in Primary Teeth.

|I) Study design: Randomized Clinical Trial

II) Study setting: The study will be conducted in the Department of Pedodontics and Preventive Dentistry

III) Study population: Primary second molar carious teeth in patients between 3 to 8 years old will be chosen for the study.

IV) Sample size estimation :

Sample size for estimating pre-post mean difference for an in-vivo study

Sample size  n= 17 per group.

Assuming 10% losses to follow up in the 6-month follow-up period, the effective sample size will be n = 17*(1/1-0.10) =18.87, say 20 per group.

Considering there will be 3 comparison groups, the total sample size requirement will be n = 20*3 =60.

Therefore, a total of 60 specimens will be included in this study.

Method Of Selection of Study Subjects:

The ethical clearance will be obtained from the institutional ethical committee. A total of 60 primary second molar teeth from patients between 3 to 8 years old will be chosen for the study. The teeth will be allocated into three groups equally and randomly comprising 20 teeth in each group (Group I: MTA, Group II: light-cured calcium silicate - TheraCal LC, and Group III: 3Mixtatin) based on the following criteria.

Inclusion criteria :

1. On clinical examination, deep carious lesion involving occlusal and proximal surfaces or multi surfaces with the gingiva appearing normal in primary second molars.
2. Mild discomfort from chemical and thermal stimuli.
3. History of dull, intermittent, but bearable pain associated with eating.
4. Restorable by a stainless-steel crown (SSC).
5. Radiographically, more than two-thirds of dentin thickness is being involved by caries approaching the pulp with intact lamina dura and periodontal ligament (PDL) space appearing normal.
6. Radiographically more than two-thirds of the root is present, with no periapical changes, and no pathologic external or internal resorption or necrosis.
7. Cooperative children and parents willing to follow the instructions and report for follow-up.

 Exclusion criteria :

1.      Acute pulpal inflammation and necrosis indicated by a history of sharp penetrating pulpalgia, tenderness on percussion, and prolonged spontaneous pain at night.

2.      Clinically, mobile tooth, discolored tooth, and a tooth with sinus opening, fistula, or abscess.

3.      Radiographically, interrupted lamina dura, internal or external root resorption, inter radicular or periapical pathoses, and widened periodontal ligament space

4.      Presence of chronic systemic diseases such as congenital or rheumatic heart disease, hepatitis, and leukemia

5.      On long-term medication such as corticosteroid therapy

6.      Physically or mentally challenged.

Withdrawal criteria:

1.      Voluntary withdrawal at any point by participants.

2.      Accidental pulp exposure.

 Method of Measurements:

A complete case history of the patient will be taken. Patients will be evaluated randomly in different 3 Groups. This study will be conducted by using a randomized clinical trial. 60 children aged between 3 to 8 years will be selected using the random allocation sampling method.

Each child’s parents or guardians will be explained in detail about the procedure in the local language (Marathi, Hindi or English). They will be informed about their right to refuse or discontinue their participation at any time and will be then asked to sign the consent form.

Study subjects will be randomly allocated into three groups:

Group I: MTA (ProRoot, Dentsply/Tulsa Dental, Tulsa, OK, USA)

Group II: TheraCal LC ( Bisco Inc., Illinois, United States of America)

Group III: 3Mixtatin (Simvastatin, Metronidazole, Cefixime, Ciprofloxacin)

METHODOLOGY:

Before the procedure, a preoperative diagnostic radiograph of the tooth with a grid will be taken. Topical anesthesia will be applied first, following which local anesthesia will be administered, after which isolation will be achieved with a rubber dam. A two-step carious lesion removal procedure will be undertaken: (1) a high-speed round diamond bur will be used to remove carious enamel and dentin, and (2) a sharp spoon excavator will be used to curette the dentin manually only to remove the infected dentin. Care will be taken not to expose the pulp. Then, a pulp capping medicament will be selected and placed in the cavity after manipulating it by following the manufacturer’s instructions.

In group I, MTA ( ProRoot, Dentsply/Tulsa Dental, Tulsa, OK, USA)powder and sterile water will be mixed for 30 seconds (following the instructions of the manufacturer) until a sandy consistency is obtained, it will be carried with an MTA carrier in the prepared cavity and light pressure will be applied by a moist cotton pellet and then temporized.

In group II, using a dispensing syringe, light-cured calcium silicate (TheraCal lc®, Bisco IncIllinois, United States of America) will be applied to the dentin surface directly and will be light-cured for 20 seconds.

In group III, the 3Mixtatin will be prepared using three commercially available antibiotics metronidazole, ciprofloxacin, and cefixime along with simvastatin powder. After removal of the capsules or coating materials that enclosed the drug products, they will be pulverized to fine powders using porcelain mortars and pestles. A total of 100 mg of metronidazole, 100 mg of ciprofloxacin, and 100 mg of cefixime will be mixed in a 1:1:1 ratio, and 2 mg of simvastatin powder will be added to the final powdered drug mix, which will be kept in a tightly capped porcelain bottle. This powder will be mixed with Macrogol and Propylene Glycol to form a creamy paste.

For the permanent restoration in all three groups, Glass ionomer cement (Medicept Xtracem GIC TYPE II) will be first placed as a cavity base. The tooth will be then prepared for an SSC, which will be fixed with glass ionomer luting cement ( Medicept Xtracem GIC TYPE I)

Immediately, a baseline radiograph will be taken. Subsequently, the tooth will be examined clinically and radiographically in the 3rd and 6th month.

Clinically, treatment will be considered successful when there is an absence of the following: pain, sensitivity to pressure, abnormal tooth mobility, and abscess. The treatment will be radiographically considered successful when there is an absence of the following: furcation radiolucency, broken lamina dura, widening of PDL space and external and internal resorption of the root. The teeth will be evaluated clinically and radiographically at 3 and 6 months.

Additional points for Research in AYUSH

Not Applicable

Additional points for RCT

i) Randomization:

The selected sample of 60 specimens will be randomly allocated to three groups using the Simple block randomization method. A predetermined, computer-generated random allocation plan will be utilized wherein 10 blocks of size 6 each will be used for equal assignment of specimens to all the comparison groups.

ii) Masking (Concealment):

The use of block randomization and unpredictable computer-generated random sequences will help in masking or concealment of treatment assignment to all the specimens.

iii) Blinding:

This is an Open-label randomized controlled trial where the investigator will be blinded to treatment assignment.

Additional points for all Experimental Studies

i) Explained intervention in required details

Before the procedure, a preoperative diagnostic radiograph of the tooth with a grid will be taken. Topical anesthesia will be applied first, following which local anesthesia will be administered, after which isolation will be achieved with a rubber dam. A two-step carious lesion removal procedure will be undertaken: (1) a high-speed round diamond bur will be used to remove carious enamel and dentin, and (2) a sharp spoon excavator will be used to curette the dentin manually only to remove the infected dentin. Care will be taken not to expose the pulp. Then, a pulp capping medicament will be selected and placed in the cavity after manipulating it by following the manufacturer’s instructions.

In group I, MTA ( ProRoot, Dentsply/Tulsa Dental, Tulsa, OK, USA)powder and sterile water will be mixed for 30 seconds (following the instructions of the manufacturer) until a sandy consistency is obtained, it will be carried with an MTA carrier in the prepared cavity and light pressure will be applied by a moist cotton pellet and then temporized.

In group II, using a dispensing syringe, light-cured calcium silicate (TheraCal lc®, Bisco IncIllinois, United States of America) will be applied to the dentin surface directly and will be light-cured for 20 seconds.

In group III, the 3Mixtatin will be prepared using three commercially available antibiotics metronidazole, ciprofloxacin, and cefixime along with simvastatin powder. After removal of the capsules or coating materials that enclosed the drug products, they will be pulverized to fine powders using porcelain mortars and pestles. A total of 100 mg of metronidazole, 100 mg of ciprofloxacin, and 100 mg of cefixime will be mixed in a 1:1:1 ratio, and 2 mg of simvastatin powder will be added to the final powdered drug mix, which will be kept in a tightly capped porcelain bottle. This powder will be mixed with Macrogol and Propylene Glycol to form a creamy paste.

For the permanent restoration in all three groups, Glass ionomer cement (Medicept Xtracem GIC TYPE II) will be first placed as a cavity base. The tooth will be then prepared for an SSC, which will be fixed with glass ionomer luting cement ( Medicept Xtracem GIC TYPE I)

Immediately, a baseline radiograph will be taken. Subsequently, the tooth will be examined clinically and radiographically in the 3rd and 6th month.

Clinically, treatment will be considered successful when there is an absence of the following: pain, sensitivity to pressure, abnormal tooth mobility, and abscess. The treatment will be radiographically considered successful when there is an absence of the following: furcation radiolucency, broken lamina dura, widening of PDL space and external and internal resorption of the root. The teeth will be evaluated clinically and radiographically at 3 and 6 months.

Duration: 18-24 months.