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NCT Number: NCT07083102

Effect of Crown Material on Gingival Microbial Colonization

* 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

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, SZAMBU

Islamabad, Federal, 44000, Pakistan

Location contact

Fatima Nasir Cheema, BDS, Post graduate resident

CONTACT

[email protected]

03227965188

Fatima Nasir Cheema, BDS, Post graduate resident

PRINCIPAL_INVESTIGATOR

Maria Shakoor Abbasi, BDS, FCPS

CONTACT

[email protected]

+923333615061

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental

Other
  • 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.

Primary outcomes

  1. Quantitative change in gingival microbial count (CFU/ml) for each microorganism over time.

    Time frame: 3 months

Secondary outcomes

  1. Comparative analysis of microbial colonization trends between PFM and Zirconia crown groups

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Fatima Nasir Cheema, BDS, Post graduate Resident

CONTACT

[email protected]

+923227965188

Maria Shakoor Abbasi, BDS, FCPS

CONTACT

[email protected]

+923333615061

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

Effect of Crown Material on Gingival Microbial Colonization: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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