Chronic PeriodontitisPhase 1NCT04697199
The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis
A Phase 1 study testing Lactobacillus Reuteri Oral Drops and Scaling and root planing in people with Chronic Periodontitis, run by Tanta University at 1 site in Egypt.
Trial summary
Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Lactobacillus Reuteri Oral Drops and Scaling and root planing
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 6 Feb 2020
- Phase
- Phase 1
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with good systemic health.
- Patients with moderate chronic periodontitis with attachment level ranging from 3-4 mm.
- Optimal compliance as evidenced by no missed treatment appointments and positive attitude towards oral hygiene.
- No gingival recession.
Who cannot join
- Patients with history of antibiotic, anti-inflammatory drugs or periodontal therapy in the preceding 6 months.
- Patients with risk factors (e.g. - smoking, uncontrolled diabetes, uncontrolled hypertension, pregnant or any other systemic disease which can alter the course of periodontal therapy).
- Patients who are allergic to lactate products.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.
Read the detailed description
The present randomized controlled clinical trial was conducted to evaluate the effects of Lactobacillus reuteri-containing probiotic suspension as an adjunct to scaling and root planing (SRP).
Material and Methods: Twenty sites from twelve chronic periodontitis patients were recruited and monitored clinically and microbiologically at baseline, three, and six months after therapy for plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL) and microbiologically or Porphyromonas gingivalis (P. gingivalis) load. Patients meeting the inclusion criteria were scheduled within one week for two sessions of SRP performed using ultrasonic scalers and hand instrumentation. After SRP, oral hygiene measures were reassured and then sites were randomly allocated to one of the two groups 10 sites each. group I (SRP only) and group II (SRP + probiotic). Group II received SRP and sub-gingival delivery of 1ml of probiotic L. reuteri suspension at baseline (immediately after SRP), one, two and four weeks using blunt syringe. Periodontal dressing was applied after placement of the drug.
- Conditions
- Chronic Periodontitis
- Being tested
- Lactobacillus Reuteri Oral Drops, Scaling and root planing
- Keywords
- Chronic periodontitis
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Reuteri Oral DropsDrug
Also called Scaling and root planing
Subgingival delivery of probiotic suspension
Scaling and root planingProcedure or surgery
Scaling and root planing using hand and ultrasonic instruments
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | patients received scaling and root planing using hand and ultrasonic instruments. Receives: Procedure: Scaling and root planing |
| Probiotic group | Active comparator | patients received SRP and by using blunt syringe, subgingival delivery of 1ml of probiotic suspension was applied to these sites at baseline (immediately after SRP), one, two and four weeks. Periodontal dressing was applied after placement of the drug.
After placement of the drug, patients were instructed to keep away from chewing hard or sticky food, brushing near the treated areas, or using any interdental aids for 24 hours. Receives: Drug: Lactobacillus Reuteri Oral Drops; Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing pocket depth
Individual acrylic stents were prepared to serve as the constant points to align the probe consistently and to reduce errors associated with probe placement. Probing pocket depth was assessed using a manual probe (UNC-15). The distance from the free gingival margin to the bottom of the pocket was recorded at six sites for each examined tooth. The probe was inserted in line with the long axis of the tooth and walked circumferentially around each surface of each tooth to detect and record the area of the deepest probe penetration. The mean probing pocket depth was obtained by summing the scores for the six sites and dividing it by six.
Measured: Baseline. 3 months. 6 months
Secondary outcomes (3)
Change in Plaque index
This index distinguishes clearly between the severity and the location of soft debris aggregates.
Measured: Baseline, 3 and 6 months
Change in Bleeding on probing
Bleeding on probing was performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds, the number of positive sites is recorded and then expressed as a percentage of the number of sites examined.
Measured: Baseline, 3 and 6 months
Change in Clinical attachment level
The distance from cementoenamel junction to the bottom of the pocket was measured in the same way as described for probing
Measured: Baseline, 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 posted6 Jan 2021
- Study start1 Sep 2018
- Primary completion6 Sep 2019
- Study completion6 Feb 2020
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.
- More trials run by Tanta 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghadeer Khalil Elbagoory, Tanta University
- Investigators
- Elbagoory, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697199
- Sponsor's protocol ID
- OMP-02-18
- Status last verified
- Jan 2021
- First submitted
- 31 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT04697199
- Acronym / sponsor ID
- OMP-02-18
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic periodontitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 6 Jan 2021 (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.
Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.
Detailed description
The present randomized controlled clinical trial was conducted to evaluate the effects of Lactobacillus reuteri-containing probiotic suspension as an adjunct to scaling and root planing (SRP).
Material and Methods: Twenty sites from twelve chronic periodontitis patients were recruited and monitored clinically and microbiologically at baseline, three, and six months after therapy for plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL) and microbiologically or Porphyromonas gingivalis (P. gingivalis) load. Patients meeting the inclusion criteria were scheduled within one week for two sessions of SRP performed using ultrasonic scalers and hand instrumentation. After SRP, oral hygiene measures were reassured and then sites were randomly allocated to one of the two groups 10 sites each. group I (SRP only) and group II (SRP + probiotic). Group II received SRP and sub-gingival delivery of 1ml of probiotic L. reuteri suspension at baseline (immediately after SRP), one, two and four weeks using blunt syringe. Periodontal dressing was applied after placement of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Procedure: Scaling and root planingpatients received scaling and root planing using hand and ultrasonic instruments. |
| Probiotic group | Active comparator | Drug: Lactobacillus Reuteri Oral Drops, Procedure: Scaling and root planingpatients received SRP and by using blunt syringe, subgingival delivery of 1ml of probiotic suspension was applied to these sites at baseline (immediately after SRP), one, two and four weeks. Periodontal dressing was applied after placement of the drug. After placement of the drug, patients were instructed to keep away from chewing hard or sticky food, brushing near the treated areas, or using any interdental aids for 24 hours. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with good systemic health.
- Patients with moderate chronic periodontitis with attachment level ranging from 3-4 mm.
- Optimal compliance as evidenced by no missed treatment appointments and positive attitude towards oral hygiene.
- No gingival recession.
Key exclusion criteria (3 listed)
- Patients with history of antibiotic, anti-inflammatory drugs or periodontal therapy in the preceding 6 months.
- Patients with risk factors (e.g. - smoking, uncontrolled diabetes, uncontrolled hypertension, pregnant or any other systemic disease which can alter the course of periodontal therapy).
- Patients who are allergic to lactate products.
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 |
|---|---|---|
| Lactobacillus Reuteri Oral DropsAlso: Scaling and root planingSubgingival delivery of probiotic suspension | Drug | Probiotic group |
| Scaling and root planingScaling and root planing using hand and ultrasonic instruments | Procedure or surgery | Placebo group, Probiotic group |
Primary outcome
Change in Probing pocket depth
Time frame: Baseline. 3 months. 6 months
Individual acrylic stents were prepared to serve as the constant points to align the probe consistently and to reduce errors associated with probe placement. Probing pocket depth was assessed using a manual probe (UNC-15). The distance from the free gingival margin to the bottom of the pocket was recorded at six sites for each examined tooth. The probe was inserted in line with the long axis of the tooth and walked circumferentially around each surface of each tooth to detect and record the area of the deepest probe penetration. The mean probing pocket depth was obtained by summing the scores for the six sites and dividing it by six.
3 secondary outcomes
Change in Plaque index
Time frame: Baseline, 3 and 6 months
Change in Bleeding on probing
Time frame: Baseline, 3 and 6 months
Change in Clinical attachment level
Time frame: Baseline, 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 6 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Elbagoory study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactobacillus Reuteri Oral Drops and Scaling and root planing in people with Chronic Periodontitis, run by Tanta 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 4 inclusion and 3 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 6 Jan 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in Probing pocket depth (time frame: Baseline. 3 months. 6 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 6 Jan 2021.