Effect of Crown Material on Gingival Microbial Colonization

Not Applicable

Not yet recruiting

• Conditions: Microbial Colonization; Missing Teeth

• Registration Number: NCT07083102
• Lead Sponsor: Pakistan Institute of Medical Sciences

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2025-08-15
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quantitative change in gingival microbial count (CFU/ml) for each microorganism over time.	3 months

Secondary Outcome Measures

Name	Time	Method
Comparative analysis of microbial colonization trends between PFM and Zirconia crown groups	3 months

Trial Locations

Locations (1)

School of Dentistry, SZAMBU; 🇵🇰 Islamabad, Federal, Pakistan