Clinical and radiographic assessment of dentin remineralization using Vitamin D3 versus Calcium hydroxide as indirect pulp capping agents in primary molars – Randomized clinical trial

Dental caries continues to be a major health concern and is also the most common dental disease, with increased prevalence among young children. Dental caries in proximity to pulp are commonly treated with a vital pulp procedure rather than a restorative technique to preserve the vitality of the primary tooth. Indirect pulp capping is where the deepest layer of the remaining affected carious dentin is covered with a layer of biocompatible material to prevent pulpal exposure and further trauma to the pulp. Vitamin D3 plays a crucial role in regulating bone metabolism and mineralization of skeletal and dental tissues. Calcium hydroxide is a material with a long history of clinical success, considered the gold standard among other pulp capping agents. It has an antibacterial activity, and it stimulates the remineralization of the remaining carious dentin. Literature review revealed an in vitro study in which Vitamin D3 is being used for odontogenic differentiation. The current study is designed to compare the efficacy of Vitamin D3 and Calcium hydroxide as indirect pulp capping agents in primary teeth at baseline, 2nd, and 6th month follow-up.

HYPOTHESIS: There is no difference between the efficacy of Vitamin D3 and Calcium hydroxide when used as indirect pulp capping agents.

METHOD:

Study design: Randomized Clinical Trial

Sample size: 60 Children (30/Group).  Source of study: Department of Paediatric and Preventive Dentistry, VMSDC, Salem.

Inclusion Criteria:

• No history of spontaneous and nocturnal pain
• No history of swelling or sinus tracts
• No radiographic signs of pathologic root resorption and furcation radiolucency
• Dental caries involving more than 2/3rd of the dentin thickness, not approaching the pulp

Exclusion criteria:

• Signs of irreversible pulpitis
• Patients who are unwilling to participate in the study
• Patients with systemic diseases/ physical disabilities

Randomization:

The randomization is achieved by a simple randomization technique using the lottery method.

Based on the inclusion criteria, a total of 60 children in the age group of 5-10 years will be selected for the study. Study participants will be allocated into 2 groups. Following Rubber dam placement, soft caries (infected dentin) removal will be done using a slow-speed handpiece and a carbide bur.

Group I - Vitamin D3 (Powder)

Vitamin D3 powder will be mixed with saline and delivered using a spoon excavator to the base of the cavity and condensed using a sterile cotton pellet moistened with saline.

Group II - Calcium Hydroxide (Powder)

Calcium hydroxide powder will be mixed with saline and delivered using a spoon excavator to the base of the cavity and condensed using a sterile cotton pellet moistened with saline.

A thick mix of type IX restorative Glass Ionomer Cement (GIC) will be placed over the indirect pulp capping agents and restored. Postoperative IOPA with Grid and film holder will be taken in paralleling technique to check the remaining dentin thickness (RDT), which will serve as the Baseline parameter. Periodic clinical and radiographic evaluations will be carried out at the 2nd and 6th months post-operatively.

Clinical Assessment:

The evaluations will be performed at baseline and at 2nd and 6th month intervals through a clinical examination according to Zurn and Seale’s pain rating scale, 2008.

Radiographic Assessment:

The evaluations will be performed at baseline and 2nd and 6th month intervals through a radiological examination. Radiographic success will be confirmed by the absence of any pathological root resorption, furcal radiolucency. IOPA grids, which are made up of copper wire, will be used with film holders. The paralleling technique will be used. The IOPA grids, when superimposed with film, show anatomic structures with grid lines. These grid lines are evenly distributed, which is 1mm part lengthwise and widthwise. The dentin remineralisation is evaluated by using a digital radiographic technique superimposed with radiolucent grid lines.