Periodontal DiseasesPhase 3RCTNCT06253988
Effect of Probiotics on Periodontitis Stage III Grade C Molar-incisor Pattern
A Phase 3 study testing Probiotic Formula in people with Periodontal Diseases, run by Al-Azhar University at 1 site in Egypt.
Trial summary
the research highlight the effectiveness of probiotics as adjuncts to SRP in the treatment of periodontitis stage III grade C molar-incisor pattern Read more about this study
- Who is it for?
- Ages 10 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Probiotic Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 10 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients have periodontitis stage III grade C molar-incisor pattern .
Who cannot join
- Pregnant or nursing women,
- smokers,
- patients received periodontal therapy,
- systemic antimicrobials or anti-inflammatory drugs in the last six
- patients with unacceptable oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of a Mixture of Lactobacillus Brevis and Lactobacillus Plantarum on the Management of Periodontitis Stage III Grade C Molar-incisor Pattern in Egyptian Patients ( Randomize Control Trial)
the research highlight the effectiveness of probiotics as adjuncts to SRP in the treatment of periodontitis stage III grade C molar-incisor pattern
Read the detailed description
Background data : Periodontitis is a common disease that represents a public health problem. Aggregatibacter actinomycetemcomitans (A. a ) especially the JP2 genotype plays a major role in the pathogenesis of periodontitis. The aim of this study is to evaluate the effect of topically applied probiotics on the management of periodontitis stage III grade C molar-incisor pattern.
Methods: Sixty-five patients having periodontitis stage III grade C molar-incisor pattern. Screening for A. actinomycetemcomians (A.a) and the JP2 genotype was done using conventional polymerase chain reaction (PCR). Patients positive for (A. a) were randomly divided into two groups. Group I: received conventional periodontal treatment combined with topically applied probiotic, while Group II: received conventional periodontal treatment only. Both groups were evaluated microbiologically and clinically. Quantitative assessment of A. a levels was done by real time PCR (qPCR) at baseline as well as one week, 4 weeks, and 12 weeks after treatment. Clinical parameters were assessed before treatment as well as 3,6 and 9 months after treatment.
- Conditions
- Periodontal Diseases
- Being tested
- Probiotic Formula, placebo formula
- Keywords
- Periodontitis, Agg. actinomycetemcomitans, JP2 genotype, PCR, local delivery drug, probiotics
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic FormulaDrug
Also called A mixture of Lactobacillus brevis and Lactobacillus plantarum
intra-pocket formula (local delivery drug)
placebo formulaDrug
Also called placebo
intra-pocket formula (local delivery drug)
| Study group | Role | What they receive |
|---|---|---|
| Group probiotic | Active comparator | received conventional periodontal treatment combined with topically applied probiotic Receives: Drug: Probiotic Formula |
| Group placebo | Placebo comparator | received conventional periodontal treatment only. Receives: Drug: placebo formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative assessment of A. actinomycetemcomians levels by picogram
Microbiological evaluation by picogram
Measured: at baseline (before treatment) used by conventional PCR
Assessment of clinical periodontal parameter : Probing pocket Depth (PPD) by mm
Clinical evaluation mm
Measured: at base line , 1 , 3 , 6 months
Assessment of clinical periodontal parameter : Clinical Attachment Level (CAL) by mm
Clinical evaluation by "mm"
Measured: at base line , 1 , 3 , 6 months
Secondary outcomes (1)
quantitative assessment of A. actinomycetemcomians levels by picogram
microbiological by picogram
Measured: baseline ,1 ,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Feb 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty-five patients having periodontitis stage III grade C molar-incisor pattern. Screening for A. actinomycetemcomians (A.a) and the JP2 genotype was done using conventional polymerase chain reaction (PCR). Patients positive for (A. a) were randomly divided into two groups. Group I: received conventional periodontal treatment combined with topically applied probiotic, while Group II: received conventional periodontal treatment only. Both groups were evaluated microbiologically and clinically.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaymaa Hussein Rafat Kotb, Sphinx university
- Investigators
- Ibrahim H Ibrahim, Ass.prof., Principal investigator, Al-Azhar UniversityMohamed A EL-Mokhtar, Prof, Study director, Assiut UniversityMohamed F Edrees, prof., Principal investigator, Al-Azhar UniversityHeba A Hammad, Ass.prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253988
- Sponsor's protocol ID
- AUAREC202300010-2
- Acronym
- RCT
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Effect of probiotics on periodontitis stage III grade C molar-incisor pattern
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of a Mixture of Lactobacillus Brevis and Lactobacillus Plantarum on the Management of Periodontitis Stage III Grade C Molar-incisor Pattern in Egyptian Patients ( Randomize Control Trial)
- ClinicalTrials.gov ID
- NCT06253988
- Acronym / sponsor ID
- RCT / AUAREC202300010-2
- Conditions
- Periodontal Diseases
- Keywords
- Periodontitis, Agg. actinomycetemcomitans, JP2 genotype, PCR, local delivery drug, probiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 12 Feb 2024 (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.
the research highlight the effectiveness of probiotics as adjuncts to SRP in the treatment of periodontitis stage III grade C molar-incisor pattern
Detailed description
Background data : Periodontitis is a common disease that represents a public health problem. Aggregatibacter actinomycetemcomitans (A. a ) especially the JP2 genotype plays a major role in the pathogenesis of periodontitis. The aim of this study is to evaluate the effect of topically applied probiotics on the management of periodontitis stage III grade C molar-incisor pattern.
Methods: Sixty-five patients having periodontitis stage III grade C molar-incisor pattern. Screening for A. actinomycetemcomians (A.a) and the JP2 genotype was done using conventional polymerase chain reaction (PCR). Patients positive for (A. a) were randomly divided into two groups. Group I: received conventional periodontal treatment combined with topically applied probiotic, while Group II: received conventional periodontal treatment only. Both groups were evaluated microbiologically and clinically. Quantitative assessment of A. a levels was done by real time PCR (qPCR) at baseline as well as one week, 4 weeks, and 12 weeks after treatment. Clinical parameters were assessed before treatment as well as 3,6 and 9 months after treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixty-five patients having periodontitis stage III grade C molar-incisor pattern. Screening for A. actinomycetemcomians (A.a) and the JP2 genotype was done using conventional polymerase chain reaction (PCR). Patients positive for (A. a) were randomly divided into two groups. Group I: received conventional periodontal treatment combined with topically applied probiotic, while Group II: received conventional periodontal treatment only. Both groups were evaluated microbiologically and clinically.
| Arm | Type | Receives |
|---|---|---|
| Group probiotic | Active comparator | Drug: Probiotic Formulareceived conventional periodontal treatment combined with topically applied probiotic |
| Group placebo | Placebo comparator | Drug: placebo formulareceived conventional periodontal treatment only. |
Who may qualify
- Ages
- 10 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients have periodontitis stage III grade C molar-incisor pattern .
Key exclusion criteria (5 listed)
- Pregnant or nursing women,
- smokers,
- patients received periodontal therapy,
- systemic antimicrobials or anti-inflammatory drugs in the last six
- patients with unacceptable oral hygiene
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 |
|---|---|---|
| Probiotic FormulaAlso: A mixture of Lactobacillus brevis and Lactobacillus plantarumintra-pocket formula (local delivery drug) | Drug | Group probiotic |
| placebo formulaAlso: placebointra-pocket formula (local delivery drug) | Drug | Group placebo |
Primary outcome
quantitative assessment of A. actinomycetemcomians levels by picogram
Time frame: at baseline (before treatment) used by conventional PCR
Microbiological evaluation by picogram
Assessment of clinical periodontal parameter : Probing pocket Depth (PPD) by mm
Time frame: at base line , 1 , 3 , 6 months
Clinical evaluation mm
Assessment of clinical periodontal parameter : Clinical Attachment Level (CAL) by mm
Time frame: at base line , 1 , 3 , 6 months
Clinical evaluation by "mm"
1 secondary outcome
quantitative assessment of A. actinomycetemcomians levels by picogram
Time frame: baseline ,1 ,3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- OrchidLink provided by the sponsor.
- National library of MedicineLink provided by the sponsor.
- web of scienceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Effect of probiotics on periodontitis stage III grade C molar-incisor pattern
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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. This study is not recruiting at the moment.
Ibrahim H Ibrahim, Ass.prof. principal investigator
Al-Azhar University
Mohamed A EL-Mokhtar, Prof study director
Assiut University
Mohamed F Edrees, prof. principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic Formula in people with Periodontal Diseases, run by Al-Azhar University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 12 Feb 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
quantitative assessment of A. actinomycetemcomians levels by picogram (time frame: at baseline (before treatment) used by conventional PCR). The study lists 3 primary outcomes in all. 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 12 Feb 2024.