Effect of Crown Material on Gingival Microbial Colonization

Pakistan Institute of Medical Sciences

Status: Not yet enrolling

Conditions: Microbial Colonization; Missing Teeth

Treatments: Other: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT07083102

SOD/ERB/2025/77

Details and patient eligibility

About

• Prior approval from SOD ethical committee has been received.

• All patients presenting to the General OPD of School of Dentistry, Islamabad will be screened. Those patients who fulfill the criteria will be referred to the Prosthodontics department.

• The patients will undergo detailed history and oral examination after informed consent (Annexure-A). Patients will undergo radiographic investigation and based on this information they will be selected for the study according to the exclusion and inclusion criteria.

• Eligible participants will be randomly assigned to one of the following groups using a computer-generated sequence with allocation concealment via sealed opaque envelopes:

  • Group A: Control group
  • Group B: Full-coverage PFM crowns
  • Group C: Full-coverage Zirconia crowns

• Baseline gingival samples will be collected with the help of sterile swab from the target tooth region prior to prosthesis placement and at the follow-up visits i.e. 1, and 3 months; both for experimental groups and control group.

• Microbial analysis will be conducted through culture techniques to quantify CFUs and identify species.

• A summary of the micro-organisms, their incubation media, temperature and time is presented in the following table:

Table 1: Summary of the micro-organisms, their incubation media, temperature and time Micro-organism Growth Media Temperature Incubation time Candida albicans Saboraud Agar 370C 24-48 hours Streptococcus mutans BHI broth 370C 24-48 hours Staphylococcus aureus BHI broth 370C 24-48 hours Porphyromonas gingivalis BHI broth 370C 18-24 hours

• Alongside, the same sample from sterile swabs will be smeared by fixating it on a microscopic slide and then Candida albicans will be stained by Periodic Acid Schiff technique, and the bacterial species using Gram staining.
• All participants will receive standardized verbal and written instructions oral hygiene instructions to control for hygiene-related variation

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 20 to 50 years.
• Both male and female patients will be selected.
• Good oral hygiene (Defined as a plaque index score ≤ 1 across all assessed surfaces and no visible calculus deposits)
• Dentate patients require fixed prostheses for the first time on mandibular pre-molars and molars.
• Patient with no history of any dental and bony pathosis (cysts, cancerous lesion).

Exclusion criteria

• Untreated periodontal diseases
• Xerostomia
• Pregnancy, lactation
• Smokers
• Individuals with systemic conditions like diabetes and immunosuppressive diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Group A: Control group

No Intervention group

Description:

Same tooth on the contra lateral side

Group B: Full-coverage PFM crowns

Experimental group

Description:

Microbial analysis will be carried out around the PFM crowns

Treatment:

Other: Experimental

Group C: Full-coverage Zirconia crowns

Experimental group

Description:

Microbial analysis will be carried out around the Full-coverage Zirconia crowns

Treatment:

Other: Experimental