Effect of Crown Material on Gingival Microbial Colonization

Summary

* 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

Conditions

• Microbial Colonization
• Missing Teeth

Interventions

OTHER

Experimental

* 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. * 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.

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-08-15

Primary Completion

2025-12-15

Completion

2025-12-15

Countries

• Pakistan

Study Locations