Comparative evaluation of clinical and radiographic outcome of Direct pulp capping and pulpotomy using MTA in primary teeth: Prospective Randomized Clinical Trial

1)     Title- Comparative evaluation of clinical and radiographic outcome of Direct pulp capping and pulpotomy in primary teeth: Prospective Randomized Clinical Trial

Primary hypothesis (Null hypothesis)-There is no difference in clinical and radiographic outcome between MTA pulpotomy and MTA direct pulp capping in primary molar teeth

Other hypothesis- There is a difference in clinical and radiographic outcome between MTA pulpotomy and MTA direct pulp capping in primary molar teeth

Primary objective- To compare and evaluate the radiographic and clinical outcomes of MTA pulpotomy and MTA direct pulp capping

Other objective- To evaluate the radiographic and clinical outcomes of pulpotomy using MTA using Zurn and Seale criteria for radiographic evaluation and scoring and modified Zurn and Seale criteria for clinical score. To evaluate the radiographic and clinical outcomes of direct pulp capping using MTA using Zurn and Seale criteria for radiographic evaluation and scoring and modified Zurn and Seale criteria for clinical score

Study design- RCT, Interventional, split mouth technique

Study population- Carious primary molar with moderate to deep carious lesion in healthy, co-operative children aged 4-9 years

Methods of data collection

After the informed consent is obtained, local anesthesia will be administered prior to isolation.

A child’s tooth meeting the aforementioned inclusion criteria was randomly allotted to each group before any treatment will begin using computer generated random numbers

A child’s quadrant will be than randomly allotted to each group before any treatment begins using computer generated random numbers

After randomization, local anesthesia will be administered prior to isolation.

All clinical and radiographical follow-up evaluations were carried out by the independent investigators (not the operator), who were blinded to the treatment used.

The time lapse between treating the other side of the mouth is 1 week to 10 days

The procedure to be followed, is as follows

DIRECT PULP CAPPING

All teeth will be treated under local anesthesia1

Complete isolation with rubber dam: The choice of isolation technique, quadrant or single tooth isolation, is subjective in nature. However, quadrant isolation is preferred, if attainable, to facilitate crown preparation under rubber dam1

Pulp exposure should be less than or equal to (1mm)3during excavation with no surrounding caries26

In the DPC group, the resulting haemorrhage will be stopped using saline cotton pellets in less than two minutes26

If needed, the procedure will be repeated for additional three minutes to a maximum of five minutes.6

No bleeding should be seen after placement of capping material26

Once the bleeding is controlled disinfection of the pulp chamber, using 3% NaOCl the exposed pulp will be scrubbed with microtip brush for disinfection of the pulp chamber

After hemostasis will be achieved, an approximately 1 mm thick layer of MTA Neoputty will be applied over and exceeding the pulp exposed areas.6

All teeth will be first lined with light cure glass ionomer cement and than restoration will be done with light cure glass ionomer cement

Next the teeth will be restored using prefabricated stainless steel crowns and rubber dam will be removed1

Post-operative radiographs will be taken  at interval of 3, 6, 12 months  to determine the proper fitting of the crowns

PULPOTOMY

All teeth will be treated under local anesthesia

Complete isolation with rubber dam: The choice of isolation technique, quadrant or single tooth isolation, is subjective in nature. However, quadrant isolation is preferred, if attainable, to facilitate crown preparation under rubber dam.

Preparation of the molar and fitting of an SSC: Several authors described crown preparation of a pulpotomized tooth at a later stage. However, crown preparation will precede the endodontic procedure as this would minimize the tooth structure loss and would be performed under local anesthesia, minimizing discomfort for the patient.

Elimination of the roof of the pulp chamber and removal of the coronal pulp tissue: Removal of the carious tissue, using a round bur. Deroofing of the pulp chamber using a large, low-speed, round bur or a #330 carbide bur. After the deroofing will be finished, the coronal pulp will be amputated. This is done using a large, low-speed, round bur (# 6 or # 8 round bur)25–27 or a sharp spoon excavator. Disinfection of the pulp chamber: Using 3% NaOCl for disinfection and physiologic saline before placing pulpotomy medicament in the teeth

Drying and control of the pulp hemorrhage using slight pressure with a moist, sterile cotton wool pellet: Bleeding will be controlled within 3–5 mins. At the end of the above stipulated time, remove the pellet, the pulp chamber will be devoid of any remnant coronal pulp tissue and hemostasis will be attained at the canal orifices. If, on removal of the moistened pellet, hemorrhage recommences, the radicular pulp is chronically inflamed, and the tooth will be treated with pulpectomy

Once the bleeding is controlled disinfection of the pulp chamber, using 3% NaOCl the exposed pulp will be scrubbed with microtip brush for disinfection of the pulp chamber and pulp stumps

Pressing the MTA NeoPutty to the walls and floor of the pulp chamber with a cotton wool pellet moistened in sterile water: The cotton pellet, placed in the pulp chamber, removed and the MTA NeoPutty will be placed. The increments compacted against the floor and walls of the chamber using a cotton pellet moistened with sterile water. The thickness of the compacted bulk of material will be 3–4 mm and will cover all of the root canal orifices and the floor, a radiograph(RVG) made at this stage to avoid any void. Filling the pulp chamber with a glass ionomer cement: The remainder of the pulp chamber will be restored with glass ionomer cement immediately

Cementation of the SSC using glass ionomer luting cement: After cementation, the excess glass ionomer cement will be removed and the proximal contacts are flossed using knotted floss.

Oral hygiene instructions and regular follow-up: Given proper oral hygiene maintenance instructions, since in most cases, discomfort or pain reported by the patient will be due to lack of brushing that area. Patients will be asked to maintain the shiny metallic appearance of the SSC.1