Chronic PeriodontitisNCT03499184
Adjunctive Probiotics in Chronic Periodontitis
A study testing P Flor locally delivered, P Flor systemically administered and Amoxil 500 mg Oral Capsule in people with Chronic Periodontitis and Probiotics, run by Ziauddin Hospital at 1 site in Pakistan.
Trial summary
This study will assess clinical and microbiological efficacy of probiotics and antibiotics in patients of chronic periodontitis as an adjunctive to scaling and root planing (SRP) in reducing bacterial count and in improving clinical periodontal parameters over the period of 12 weeks.Also the comparison between these… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Probiotics
- What is being tested?
- P Flor locally delivered, P Flor systemically administered and Amoxil 500 mg Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2017to 1 Oct 2018
- Phase
- Interventional
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with clinically diagnosed chronic periodontitis with a pocket depth of ≥4mm.
- Patients with age ≥30 years.
Who cannot join
- Handicapped patients who are physically or mentally unable to maintain their oral hygiene.
- Pregnant and lactating females.
- Patients with habits of smoking, chewing tobacco and alcohol consumption.
- Patients on local or systemic antibiotic treatment.
- Patients with any systemic diseases.
- Patients with the history of any periodontal therapy within last 6 months.
- Patients undergoing orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotic Along With Scaling and Root Planing in the Treatment of Chronic Periodontitis
This study will assess clinical and microbiological efficacy of probiotics and antibiotics in patients of chronic periodontitis as an adjunctive to scaling and root planing (SRP) in reducing bacterial count and in improving clinical periodontal parameters over the period of 12 weeks.Also the comparison between these adjunctives will be made for clinical assessment clinical periodontal parameters will be taken .these parameters plaque index (PI), gingival index (GI), clinical attachment loss (CAL) and pocket probing depth (PPD) for microbiological assessment plaque sample will be taken, DNA will be extracted and then sample will be processed through quantitative polymerase chain reaction (qPCR) for quantitative analysis of bacterial count of porphyromonas gingivalis.
Read the detailed description
In this clinical trial total 60 participants of clinically diagnosed chronic periodontitis will be recruited after taking a written consent for their approval. Participants will be divided into 3 groups A, B and C through the process of randomization using a method of opaque sealed envelopes. A research assistant will be hired for the purpose of randomization and allocation concealment. All participants will be asked to pick an opaque envelope containing the details of treatment products. After randomization plaque sample will be obtained from the depth of periodontal pockets and all the clinical periodontal parameters will be recorded in every participant. Then all the participants will undergo SRP. After SRP group A will be given antibiotics Amoxicillin 500 milligrams (mg) for 3 times a day (TDS) and Metronidazole 400 milligrams (mg) for twice a day (BD) for 5 days. Group B will be given probiotics lactobacillus reuteri 1.2 billion colony forming unit (CFU) sachets twice daily for swallowing with water for 12 weeks. Group C will be given lactobacillus sachets of same amount and participant will be asked to mix it with little amount of water and apply it on teeth with the toothbrush twice daily after brushing with standard tooth paste for 12 weeks. Patients will be recalled at the interval of 3, 6, 9 and 12 weeks for the recording of clinical periodontal parameters. After completion of trial plaque sample will be taken again from every participant and will be processed through qPCR to check bacterial count of porphyromonas gingivalis before and after treatment. Whereas comparison between clinical periodontal parameters will be made at the interval of 0, 3, 6, 9, 12 weeks.
- Conditions
- Chronic Periodontitis, Probiotics
- Being tested
- P Flor locally delivered, P Flor systemically administered, Amoxil 500 mg Oral Capsule, Flagyl 400 mg Tablet
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P Flor locally deliveredDietary supplement
Locally delivered Lactobacillus reuteri 1.2 CFU per gram
P Flor systemically administeredDietary supplement
Systemically administered Lactobacillus reuteri 1.2 CFU per gram
Amoxil 500 mg Oral CapsuleDrug
Systemically administered Amoxil 500 mg thrice daily
Flagyl 400 mg TabletDrug
Systemically administered Metronidazole 400 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Local Probiotics | Experimental | P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks Receives: Dietary Supplement: P Flor locally delivered |
| Systemic Probiotics | Experimental | P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks Receives: Dietary Supplement: P Flor systemically administered |
| Systemic Antibiotics | Active comparator | Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days Receives: Drug: Amoxil 500 mg Oral Capsule; Drug: Flagyl 400 mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periodontal pocket depth (PPD)
It is the distance from tip of free gingival margin to the base of pocket
Measured: Baseline, 3, 6, 9 and 12 weeks
Change in clinical attachment level (CAL)
It is the distance from cementoenamel junction to the base of the pocket around the tooth
Measured: Baseline, 3, 6, 9 and 12 weeks
Change in bacterial load of Porphyromonas gingivalis
Bacterial count or the quantity of porphyromonas gingivalis in the sample
Measured: Baseline and 12 weeks after completion of trial
Secondary outcomes (2)
Change in the Plaque index (PI)
How much surface of tooth is covered by the plaque will be recorded.
Measured: Baseline, 3, 6, 9 and 12 weeks
Change in Gingival index (GI)
Gingival color texture and inflammation will be recorded.
Measured: Baseline, 3, 6, 9 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Nov 2017
- Primary completion1 Sep 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Ikram, MPhil Trainee, Ziauddin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499184
- Sponsor's protocol ID
- 0220817SIOB
- Status last verified
- Mar 2019
- First submitted
- 3 Apr 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Along With Scaling and Root Planing in the Treatment of Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03499184
- Acronym / sponsor ID
- 0220817SIOB
- Conditions
- Chronic Periodontitis, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ziauddin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 17 Apr 2018 (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 study will assess clinical and microbiological efficacy of probiotics and antibiotics in patients of chronic periodontitis as an adjunctive to scaling and root planing (SRP) in reducing bacterial count and in improving clinical periodontal parameters over the period of 12 weeks.Also the comparison between these adjunctives will be made for clinical assessment clinical periodontal parameters will be taken .these parameters plaque index (PI), gingival index (GI), clinical attachment loss (CAL) and pocket probing depth (PPD) for microbiological assessment plaque sample will be taken, DNA will be extracted and then sample will be processed through quantitative polymerase chain reaction (qPCR) for quantitative analysis of bacterial count of porphyromonas gingivalis.
Detailed description
In this clinical trial total 60 participants of clinically diagnosed chronic periodontitis will be recruited after taking a written consent for their approval. Participants will be divided into 3 groups A, B and C through the process of randomization using a method of opaque sealed envelopes. A research assistant will be hired for the purpose of randomization and allocation concealment. All participants will be asked to pick an opaque envelope containing the details of treatment products. After randomization plaque sample will be obtained from the depth of periodontal pockets and all the clinical periodontal parameters will be recorded in every participant. Then all the participants will undergo SRP. After SRP group A will be given antibiotics Amoxicillin 500 milligrams (mg) for 3 times a day (TDS) and Metronidazole 400 milligrams (mg) for twice a day (BD) for 5 days. Group B will be given probiotics lactobacillus reuteri 1.2 billion colony forming unit (CFU) sachets twice daily for swallowing with water for 12 weeks. Group C will be given lactobacillus sachets of same amount and participant will be asked to mix it with little amount of water and apply it on teeth with the toothbrush twice daily after brushing with standard tooth paste for 12 weeks. Patients will be recalled at the interval of 3, 6, 9 and 12 weeks for the recording of clinical periodontal parameters. After completion of trial plaque sample will be taken again from every participant and will be processed through qPCR to check bacterial count of porphyromonas gingivalis before and after treatment. Whereas comparison between clinical periodontal parameters will be made at the interval of 0, 3, 6, 9, 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Local Probiotics | Experimental | Dietary Supplement: P Flor locally deliveredP Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks |
| Systemic Probiotics | Experimental | Dietary Supplement: P Flor systemically administeredP Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks |
| Systemic Antibiotics | Active comparator | Drug: Amoxil 500 mg Oral Capsule, Drug: Flagyl 400 mg TabletAmoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with clinically diagnosed chronic periodontitis with a pocket depth of ≥4mm.
- Patients with age ≥30 years.
Key exclusion criteria (7 listed)
- Handicapped patients who are physically or mentally unable to maintain their oral hygiene.
- Pregnant and lactating females.
- Patients with habits of smoking, chewing tobacco and alcohol consumption.
- Patients on local or systemic antibiotic treatment.
- Patients with any systemic 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 |
|---|---|---|
| P Flor locally deliveredLocally delivered Lactobacillus reuteri 1.2 CFU per gram | Dietary supplement | Local Probiotics |
| P Flor systemically administeredSystemically administered Lactobacillus reuteri 1.2 CFU per gram | Dietary supplement | Systemic Probiotics |
| Amoxil 500 mg Oral CapsuleSystemically administered Amoxil 500 mg thrice daily | Drug | Systemic Antibiotics |
| Flagyl 400 mg TabletSystemically administered Metronidazole 400 mg twice daily | Drug | Systemic Antibiotics |
Primary outcome
Change in periodontal pocket depth (PPD)
Time frame: Baseline, 3, 6, 9 and 12 weeks
It is the distance from tip of free gingival margin to the base of pocket
Change in clinical attachment level (CAL)
Time frame: Baseline, 3, 6, 9 and 12 weeks
It is the distance from cementoenamel junction to the base of the pocket around the tooth
Change in bacterial load of Porphyromonas gingivalis
Time frame: Baseline and 12 weeks after completion of trial
Bacterial count or the quantity of porphyromonas gingivalis in the sample
2 secondary outcomes
Change in the Plaque index (PI)
Time frame: Baseline, 3, 6, 9 and 12 weeks
Change in Gingival index (GI)
Time frame: Baseline, 3, 6, 9 and 12 weeks
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 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
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?
A study testing P Flor locally delivered, P Flor systemically administered and Amoxil 500 mg Oral Capsule in people with Chronic Periodontitis and Probiotics, run by Ziauddin Hospital 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 2 inclusion and 7 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 Mar 2019. 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?
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?
Change in periodontal pocket depth (PPD) (time frame: Baseline, 3, 6, 9 and 12 weeks). 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 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.