Effect of Crown Material on Gingival Microbial Colonization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental.
- Who it may be relevant to
- Registry conditions: Microbial Colonization, Missing Teeth. Basic parameters: 20 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Crown Material on Gingival Microbial Colonization: A Randomized Clinical Trial
Overview
* 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
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
Primary outcome measures
- Quantitative change in gingival microbial count (CFU/ml) for each microorganism over time. [Time frame: 3 months]
Secondary outcome measures (1)
- Comparative analysis of microbial colonization trends between PFM and Zirconia crown groups [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- School of Dentistry, SZAMBU — Islamabad
Identifiers
NCT: NCT07083102 · SOD/ERB/2025/77