PeriodontitisA Case-ControlNCT07579338
Detection And Quantification of Eubacterium Saphenum and Porphyromonas Gingivalis In Periodontal Health and Disease
An observational study of Periodontitis and Periodontal Health, run by Sarah Al-Rihaymee at 1 site in Iraq.
Trial summary
This case-control study will be conducted between January and June 2026 and will include 148 participants aged over 30 years to investigate differences between individuals with periodontitis (n = 111) and those with periodontal health (n = 37). Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Health
- What is being tested?
- Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep i
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 148 participants
- Where
- 1 siteIraq
- Study dates
- 31 Jan 2026to 1 Aug 2026
- Phase
- Observational
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is an observational case-control study. Patients with generalized unstable periodontitis, at any grade, with (>4 mm) probing pocket depths (PPD), as well as periodontal health participants, will be recruited from the Department of Periodontics, College of Dentistry, University of Babylon. A written consent forms will be obtained from all participants. Ethical approval will be obtained.
Who may be able to join
- (1) Participants aged > 30 years old. (2) Participants who have at least 20 teeth
Who cannot join
- 1) Participants who have active caries. (2) Participants who are undergoing orthodontic treatment. (3) Participants with a history of antibiotic use within the last three months will not be eligible.
- Participants with a history of valve replacement which requires prophylactic antibiotic coverage. (5) Participants who require systemic or topical non-steroidal anti-inflammatory drugs within the past three months. Participants who are pregnant or lactating women. (6) Participants with a history of alcohol use. (7) Participants who had periodontal therapy within the last six months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Detection And Quantification of Eubacterium Saphenum and Porphyromonas Gingivalis In Periodontal Health and Disease: A Case-Control Study
This case-control study will be conducted between January and June 2026 and will include 148 participants aged over 30 years to investigate differences between individuals with periodontitis (n = 111) and those with periodontal health (n = 37). Participants will be selected based on strict inclusion and exclusion criteria to minimize confounding factors, and ethical approval along with informed consent will be obtained prior to participation. Periodontitis will be diagnosed according to the 2017 classification criteria, requiring clinical attachment loss and periodontal pocketing, while periodontal health will be defined by minimal bleeding on probing, shallow pocket depths, and absence of attachment loss. The sample size will be determined using G*Power to ensure adequate statistical power.
Clinical periodontal parameters-including plaque index, gingival bleeding index, probing pocket depth, and clinical attachment loss-will be recorded using standardized methods at multiple sites per tooth by calibrated examiners to ensure reliability. Following clinical assessment, subgingival biofilm samples will be collected using sterile paper points under controlled conditions and stored at -80°C for subsequent real-time PCR analysis. Calibration procedures, including inter- and intra-examiner agreement assessed by intraclass correlation coefficients, will be implemented to enhance measurement consistency. Overall, the study will combine rigorous clinical evaluation with molecular techniques to enable a comprehensive assessment of periodontal status and associated microbiological factors.
Read the detailed description
This case-control study will be conducted between January and June 2026 and will include a total of 148 participants aged over 30 years. The study population will consist of 111 subjects with periodontitis and 37 subjects with periodontal health. Ethical approval will be obtained from the Institutional Ethics Review Board (Certificate No. 2015-16/1118), and written informed consent will be secured from all participants prior to examination. Eligible individuals will be selected based on predefined inclusion and exclusion criteria and will be categorized into a healthy group and a periodontitis group according to clinical periodontal parameters. Inclusion criteria will require participants to be over 30 years old and to have at least 20 teeth. Exclusion criteria will include individuals with active caries, those undergoing orthodontic treatment, recent antibiotic use within three months, history of valve replacement requiring prophylactic antibiotics, recent use of non-steroidal anti-inflammatory drugs, pregnancy or lactation, alcohol use, and receipt of periodontal therapy within the last six months.
Participants in the periodontitis group will be diagnosed based on the 2017 classification, defined by interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth or buccal/oral CAL ≥3 mm with probing pocket depth (PPD) >3 mm at ≥2 teeth. Cases will be further characterized as generalized periodontitis affecting more than 30% of teeth, with unstable disease indicated by sites exhibiting PPD ≥5 mm or PPD ≥4 mm with bleeding on probing (BOP), and staged from I to IV. The control group will include individuals with periodontal health, defined by BOP <10%, PPD ≤3 mm, and absence of attachment loss. The sample size will be calculated using G*Power software (version 3.1.9.7) based on an expected prevalence of 25% in healthy individuals and 50% in periodontitis patients, with 80% power and a significance level of 0.05, resulting in a required total of 148 participants.
Clinical periodontal parameters will be assessed following participant selection. Plaque Index (PI) will be recorded at four sites per tooth using a disclosing agent and a dichotomous scoring system. Gingival Bleeding Index (GBI) will be evaluated at the same sites using a UNC-15 periodontal probe, with bleeding recorded 30 seconds after probing. Probing pocket depth (PPD) and clinical attachment loss (CAL) will be measured at six sites per tooth using a manual periodontal probe. To ensure measurement reliability, inter-examiner calibration will be performed between two examiners on selected quadrants and sites, while intra-examiner calibration will be conducted by repeating measurements in two sessions. Agreement will be analyzed using the intraclass correlation coefficient (ICC) in SPSS.
Following clinical examination, subgingival biofilm samples will be collected from selected sites. The sampling area will be isolated with cotton rolls to prevent contamination, and sterile paper points will be inserted into the base of the periodontal pocket for 30 seconds. Samples will then be transferred into sterile tubes containing preservative solution, properly labeled, and stored at -80°C to maintain DNA integrity. These samples will subsequently be analyzed using real-time polymerase chain reaction (RT-PCR) to identify and quantify bacterial presence.
- Conditions
- Periodontitis, Periodontal Health
- Being tested
- Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep i
- Keywords
- periodontitis, Plaque, E.saphenum, P. gingivalis
- Medical subject headings
- Periodontitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep iDiagnostic test
Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep it dry and avoid saliva contamination. Then, a sterile paper point will be gently inserted into the selected sites reaching the base of the pocket and will be kept for 30 seconds. Then, the paper point will be carefully withdrawn and placed immediately into a sterile tube containing a preservative solution. The tube will be labeled with details, including the patient ID, site location, and date, and then sealed tightly to prevent contamination. The sample was stored at -80°C to preserve DNA quality for subsequent Real time-PCR analysis.
| Study group | Role | What they receive |
|---|---|---|
| Peiordontal health | In the control group, the participants were diagnosed periodontal health characterized by BOP < 10%, PPD ≤ 3mm, and intact periodontium with no probable attachment loss (Chapple et al., 2018) Receives: Diagnostic Test: Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep i | |
| Periodontitis | Participants were diagnosed as periodontitis when they have interdental CAL detectable at ≥2 non-adjacent teeth, or facial and/or oral CAL ≥3 mm associated with pocketing >3mm detectable at ≥ 2 teeth. The diagnosis statement was: Generalized periodontitis (>30% of teeth having CAL), Unstable status (having at least one site with PPD ≥5 mm or PPD ≥4 mm with BOP), at stages I-IV (Tonetti, Greenwell and Kenneth S. Kornman, 2018) Receives: Diagnostic Test: Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep i |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of E. saphenum in periodontitis and periodontal health groups.
Measuring the level of E. saphenum and P. ginigvalis in study groups using Real-time PCR
Measured: 8 MONTHS
Secondary outcomes (1)
Comparing the level of E. saphenum and P. gingivalis between study groups.
Comparing the level of E. saphenum and P. gingivalis between study groups.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start31 Jan 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Al-Rihaymee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Al-Rihaymee, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579338
- Sponsor's protocol ID
- 2/5/2026
- Other IDs
- Sarah
- Acronym
- A Case-Control
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided Yet.
Publications
Castillo Y, Delgadillo NA, Neuta Y, Iniesta M, Sanz M, Herrera D, Pianeta R, Lafaurie GI, Castillo DM. Design and validation of a quantitative polymerase chain reaction test for the identification and quantification of uncultivable bacteria associated with periodontitis. Arch Oral Biol. 2023 Oct;154:105758. doi: 10.1016/j.archoralbio.2023.105758. Epub 2023 Jul 4.
PubMed 37419062
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection And Quantification of Eubacterium Saphenum and Porphyromonas Gingivalis In Periodontal Health and Disease: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07579338
- Acronym / sponsor ID
- A Case-Control / 2/5/2026
- Conditions
- Periodontitis, Periodontal Health
- Keywords
- periodontitis, Plaque, E.saphenum, P. gingivalis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Sarah Al-RihaymeeUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 12 May 2026 (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.
This case-control study will be conducted between January and June 2026 and will include 148 participants aged over 30 years to investigate differences between individuals with periodontitis (n = 111) and those with periodontal health (n = 37). Participants will be selected based on strict inclusion and exclusion criteria to minimize confounding factors, and ethical approval along with informed consent will be obtained prior to participation. Periodontitis will be diagnosed according to the 2017 classification criteria, requiring clinical attachment loss and periodontal pocketing, while periodontal health will be defined by minimal bleeding on probing, shallow pocket depths, and absence of attachment loss. The sample size will be determined using G*Power to ensure adequate statistical power.
Clinical periodontal parameters-including plaque index, gingival bleeding index, probing pocket depth, and clinical attachment loss-will be recorded using standardized methods at multiple sites per tooth by calibrated examiners to ensure reliability. Following clinical assessment, subgingival biofilm samples will be collected using sterile paper points under controlled conditions and stored at -80°C for subsequent real-time PCR analysis. Calibration procedures, including inter- and intra-examiner agreement assessed by intraclass correlation coefficients, will be implemented to enhance measurement consistency. Overall, the study will combine rigorous clinical evaluation with molecular techniques to enable a comprehensive assessment of periodontal status and associated microbiological factors.
Detailed description
This case-control study will be conducted between January and June 2026 and will include a total of 148 participants aged over 30 years. The study population will consist of 111 subjects with periodontitis and 37 subjects with periodontal health. Ethical approval will be obtained from the Institutional Ethics Review Board (Certificate No. 2015-16/1118), and written informed consent will be secured from all participants prior to examination. Eligible individuals will be selected based on predefined inclusion and exclusion criteria and will be categorized into a healthy group and a periodontitis group according to clinical periodontal parameters. Inclusion criteria will require participants to be over 30 years old and to have at least 20 teeth. Exclusion criteria will include individuals with active caries, those undergoing orthodontic treatment, recent antibiotic use within three months, history of valve replacement requiring prophylactic antibiotics, recent use of non-steroidal anti-inflammatory drugs, pregnancy or lactation, alcohol use, and receipt of periodontal therapy within the last six months.
Participants in the periodontitis group will be diagnosed based on the 2017 classification, defined by interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth or buccal/oral CAL ≥3 mm with probing pocket depth (PPD) >3 mm at ≥2 teeth. Cases will be further characterized as generalized periodontitis affecting more than 30% of teeth, with unstable disease indicated by sites exhibiting PPD ≥5 mm or PPD ≥4 mm with bleeding on probing (BOP), and staged from I to IV. The control group will include individuals with periodontal health, defined by BOP <10%, PPD ≤3 mm, and absence of attachment loss. The sample size will be calculated using G*Power software (version 3.1.9.7) based on an expected prevalence of 25% in healthy individuals and 50% in periodontitis patients, with 80% power and a significance level of 0.05, resulting in a required total of 148 participants.
Clinical periodontal parameters will be assessed following participant selection. Plaque Index (PI) will be recorded at four sites per tooth using a disclosing agent and a dichotomous scoring system. Gingival Bleeding Index (GBI) will be evaluated at the same sites using a UNC-15 periodontal probe, with bleeding recorded 30 seconds after probing. Probing pocket depth (PPD) and clinical attachment loss (CAL) will be measured at six sites per tooth using a manual periodontal probe. To ensure measurement reliability, inter-examiner calibration will be performed between two examiners on selected quadrants and sites, while intra-examiner calibration will be conducted by repeating measurements in two sessions. Agreement will be analyzed using the intraclass correlation coefficient (ICC) in SPSS.
Following clinical examination, subgingival biofilm samples will be collected from selected sites. The sampling area will be isolated with cotton rolls to prevent contamination, and sterile paper points will be inserted into the base of the periodontal pocket for 30 seconds. Samples will then be transferred into sterile tubes containing preservative solution, properly labeled, and stored at -80°C to maintain DNA integrity. These samples will subsequently be analyzed using real-time polymerase chain reaction (RT-PCR) to identify and quantify bacterial presence.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peiordontal health | – | Diagnostic Test: Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep iIn the control group, the participants were diagnosed periodontal health characterized by BOP < 10%, PPD ≤ 3mm, and intact periodontium with no probable attachment loss (Chapple et al., 2018) |
| Periodontitis | – | Diagnostic Test: Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep iParticipants were diagnosed as periodontitis when they have interdental CAL detectable at ≥2 non-adjacent teeth, or facial and/or oral CAL ≥3 mm associated with pocketing >3mm detectable at ≥ 2 teeth. The diagnosis statement was: Generalized periodontitis (>30% of teeth having CAL), Unstable status (having at least one site with PPD ≥5 mm or PPD ≥4 mm with BOP), at stages I-IV (Tonetti, Greenwell and Kenneth S. Kornman, 2018) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is an observational case-control study. Patients with generalized unstable periodontitis, at any grade, with (>4 mm) probing pocket depths (PPD), as well as periodontal health participants, will be recruited from the Department of Periodontics, College of Dentistry, University of Babylon. A written consent forms will be obtained from all participants. Ethical approval will be obtained.
Key inclusion criteria (1 listed)
- (1) Participants aged > 30 years old. (2) Participants who have at least 20 teeth
Key exclusion criteria (2 listed)
- 1) Participants who have active caries. (2) Participants who are undergoing orthodontic treatment. (3) Participants with a history of antibiotic use within the last three months will not be eligible.
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 |
|---|---|---|
| Microbiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep iMicrobiological sampling After recording the clinical periodontal parameters, subgingival biofilm samples were collected. After selecting the sampling site, it was isolated with cotton rolls to keep it dry and avoid saliva contamination. Then, a sterile paper point will be gently inserted into the selected sites reaching the base of the pocket and will be kept for 30 seconds. Then, the paper point will be carefully withdrawn and placed immediately into a sterile tube containing a preservative solution. The tube will be labeled with details, including the patient ID, site location, and date, and then sealed tightly to prevent contamination. The sample was stored at -80°C to preserve DNA quality for subsequent Real time-PCR analysis. | Diagnostic test | Peiordontal health, Periodontitis |
Primary outcome
The level of E. saphenum in periodontitis and periodontal health groups.
Time frame: 8 MONTHS
Measuring the level of E. saphenum and P. ginigvalis in study groups using Real-time PCR
1 secondary outcome
Comparing the level of E. saphenum and P. gingivalis between study groups.
Time frame: 8 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 12 May 2026.
- Background: PubMed 37419062Castillo Y, Delgadillo NA, Neuta Y, Iniesta M, Sanz M, Herrera D, Pianeta R, Lafaurie GI, Castillo DM. Design and validation of a quantitative polymerase chain reaction test for the identification and quantification of uncultivable bacteria associated with periodontitis. Arch Oral Biol. 2023 Oct;154:105758. doi: 10.1016/j.archoralbio.2023.105758. Epub 2023 Jul 4.
- Individual participant dataSharing planned: Undecided. Undecided Yet.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Periodontal Health, run by Sarah Al-Rihaymee at 1 site in Iraq.
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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 12 May 2026. 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 Iraq. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of E. saphenum in periodontitis and periodontal health groups. (time frame: 8 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07579338, which also lists 1 linked publication.
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 12 May 2026.