Microbial ColonizationNCT07083102
Effect of Crown Material on Gingival Microbial Colonization
A study testing Experimental in people with Microbial Colonization and Missing Teeth, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Missing Teeth
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Untreated periodontal diseases
- Xerostomia
- Pregnancy, lactation
- Smokers
- Individuals with systemic conditions like diabetes and immunosuppressive diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
School of Dentistry, SZAMBU
Islamabad, Federal, 44000
Fatima Nasir Cheema, BDS, Post graduate resident, 03227965188, fatimanasir969@gmail.com
Maria Shakoor Abbasi, BDS, FCPS, +923333615061, maria_shakoor@hotmail.com
About this study
Official title: Effect of Crown Material on Gingival Microbial Colonization: A Randomized Clinical Trial
- 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
- Being tested
- Experimental
- Medical subject headings
- Communicable Diseases, Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Control group | No intervention | Same tooth on the contra lateral side |
| Group B: Full-coverage PFM crowns | Experimental | Microbial analysis will be carried out around the PFM crowns Receives: Other: Experimental |
| Group C: Full-coverage Zirconia crowns | Experimental | Microbial analysis will be carried out around the Full-coverage Zirconia crowns Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative change in gingival microbial count (CFU/ml) for each microorganism over time.
Measured: 3 months
Secondary outcomes (1)
Comparative analysis of microbial colonization trends between PFM and Zirconia crown groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatima Nasir Cheema, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083102
- Sponsor's protocol ID
- SOD/ERB/2025/77
- Status last verified
- Jun 2025
- First submitted
- 16 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Crown Material on Gingival Microbial Colonization: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07083102
- Acronym / sponsor ID
- SOD/ERB/2025/77
- Conditions
- Microbial Colonization, Missing Teeth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Control group | No intervention | –Same tooth on the contra lateral side |
| Group B: Full-coverage PFM crowns | Experimental | Other: ExperimentalMicrobial analysis will be carried out around the PFM crowns |
| Group C: Full-coverage Zirconia crowns | Experimental | Other: ExperimentalMicrobial analysis will be carried out around the Full-coverage Zirconia crowns |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- Untreated periodontal diseases
- Xerostomia
- Pregnancy, lactation
- Smokers
- Individuals with systemic conditions like diabetes and immunosuppressive diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group B: Full-coverage PFM crowns, Group C: Full-coverage Zirconia crowns |
Primary outcome
Quantitative change in gingival microbial count (CFU/ml) for each microorganism over time.
Time frame: 3 months
1 secondary outcome
Comparative analysis of microbial colonization trends between PFM and Zirconia crown groups
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Microbial Colonization and Missing Teeth, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatima Nasir Cheema, BDS, Post graduate Resident (+923227965188, fatimanasir969@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative change in gingival microbial count (CFU/ml) for each microorganism over time. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.