Effect of growth factor derived from patients blood on pulp in teeth with deep caries

Phase 3

Not yet recruiting

Conditions: Dental caries, unspecified,

Registration Number: CTRI/2023/08/056437

Lead Sponsor: SRM Dental College

Brief Summary: Dental pulp is a highly specialized mesenchymal tissue with a variety of cells that include stem cells which provide an excellent formative ability to the pulp. Preserving the pulpâ€™s vitality, therefore, is of utmost importance for the viability and longevity of teeth as pulp is the main source of nutrition and repair of the tooth. Direct pulp capping (DPC) is a procedure for treating exposed vital pulp with a biocompatible dental material to facilitate the formation of reparative dentin and to maintain vital pulp. This procedure aims at maintaining the pulp in a vital and healthy state, by preventing bacterial ingress by creating a good seal and inducing dentin bridge formation at the site of exposure.

Of the various pulp capping agents based on calcium silicate cements, Biodentine is a bioactive, biocompatible material which has a stimulatory effect on vital dental pulp cells in turn regulating tertiary dentin formation. Studies have shown that Biodentine has enhanced mechanical properties and ease of application along with good marginal seal compared to MTA while showing a good pulpal response.

Tissue engineering concepts have been adapted for regeneration of pulp-dentin complex, and in vital pulp therapy as well; which includes the use of various platelet concentrate products like Platelet Rich Plasma (PRP) and Platelet Rich Fibrin (PRF) as effective agents with multiple studies evaluating them with results showing high success rates.

Recently, the use of Concentrated Growth Factor (CGF), an advanced second generation platelet concentrate as a direct pulp capping agent has shown promising results as they exhibit enhanced cell proliferation and differentiation that are important factors for mechanisms of repair of hard and soft tissues.

One of the key prognostic factors for a successful direct pulp capping procedure is the immediate placement of a permanent restoration. This is usually done using Glass Ionomer cement (GIC) as a liner over the pulp capping material followed by a Composite resin restoration. Since Biodentine was introduced to dentistry as a dentin replacement material, multiple studies have been conducted to assess its performance with promising results. Studies have concluded that Biodentine can be used as the material of choice under direct composite resin restorations for immediate restorations

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|Each of the above materials have shown promising results when used as a direct pulp capping agent in teeth, however to the best of our knowledge studies to determine the synergistic effect of these biocompatible agents is unexplored.

Our null hypothesis is that there is no difference in the vitality status of teeth subjected to direct pulp capping with CGF, Biodentine or a combination of CGF and Biodentine.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

Patients of age group 18-45 years of either gender, under ASA category I and II 2.
Maxillary and Mandibular Premolars and Permanent Molars with symptoms of Reversible Pulpitis and Radiographic evidence of deep caries approximating pulp.
No evidence of widening of periodontal ligament, absence of any furcation radiolucency and periapical pathology.
Absence of tenderness to percussion 5.
Positive response to cold and electric pulp testing 6.
Periodontally healthy individuals.

Exclusion Criteria

Teeth with Symptoms of Irreversible pulpitis and Pulp necrosis 2.
Negative response to cold and electric pulp testing 3.
Evidence of Periapical pathology 4.
Periodontally compromised teeth 5.
Pregnant women, in view of requirements for radiographs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To check the vitality of the tooth	3months, 6 months & 1 year

Secondary Outcome Measures

Name	Time	Method
Dentin bridge formation	6 months & 1 year

Trial Locations

Locations (1): SRM Dental College
🇮🇳
Chennai, TAMIL NADU, India
SRM Dental College
🇮🇳Chennai, TAMIL NADU, India
Dr Sancia Mary Sam
Principal investigator
9867874795
dr.sanciasam@gmail.com