Orthodontic Appliance ComplicationNCT06641960
Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment
A study testing Probiotics and Traditional treatment in people with Orthodontic Appliance Complication, run by Damascus University at 1 site in Syria.
Trial summary
Fifty patients needing non-extraction-based metallic orthodontic treatment will be divided randomly into the probiotic group and the control group. In each group, they will brush their teeth regularly while receiving orthodontic treatment. Only the probiotic group will take probiotic tablets for six months. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Probiotics and Traditional treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSyria
- Study dates
- 5 Mar 2023to 17 Jun 2024
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult healthy male and female patients aged 18-25 years.
- Patients eligible for full arch upper and lower fixed labial orthodontic appliance treatment and molar band.
- Patients with malocclusion class I, II, or III without crowding on the anterior teeth.
- Permanent occlusion and existence of all the upper and lower teeth (except third molars).
- Good oral and periodontal health:
- Probing depth < 4 mm
Show all 9Show fewer
- No radiographic evidence of bone loss.
- Gingival index ≤ 1
- Plaque index ≤ 1
Who cannot join
- Previous orthodontic treatment history.
- Patients with any systemic disorder that could influence periodontal conditions or response to treatment (such as hypertension, diabetes, or immunological disorders).
- Patients were on systemic drugs, i.e., antibiotics, hypertensives, analgesics, hormonal drugs, sedatives, and anti-seizure medication, within three months before the baseline examination.
- Patients who were allergic to ingredients of the probiotics lozenges.
- Those undergoing periodontal treatment within three months before the baseline examination.
- Smokers, pregnant or lactating women.
- Regular use of antibacterial mouthwash.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Damascus, DM20 HAJ72
About this study
Official title: The Effectiveness of Probiotics on Oral Health During Adult Orthodontic Treatment With Fixed Appliances: A Two-arm Parallel-group Randomized Controlled Clinical Trial
Fifty patients needing non-extraction-based metallic orthodontic treatment will be divided randomly into the probiotic group and the control group. In each group, they will brush their teeth regularly while receiving orthodontic treatment. Only the probiotic group will take probiotic tablets for six months.
Clinical parameters will be assessed before and during orthodontic treatment and after 3 and 6 months during treatment.
Read the detailed description
Each subject will be examined completely to ensure eligibility before enrolling in the study. The operator will then inform them about the study's aim and ask them to provide written informed consent. Patients will receive professional scaling, polishing, and oral hygiene instruction before the research starts.
Regarding the probiotic, (PRODENTIS) is commercially available in Sweden and the USA. Probiotics prepared by Bio-Gaia AB (Stockholm, Sweden). Each probiotic tablet contains two strains of probiotic lactic acid bacteria of human origin: L. reuteri DSM 17938 and L. reuteri ATCC (PTA 5289), each at a minimum of 1 × 108 CFU per lozenge. The tablets should be stored at a temperature below 25 ◦C. Dosage instructions will be prescribed per the manufacturer's recommendations at a preventive dosage of 1 lozenge/day (after dinner and teeth brushing).
Regarding the clinical parameters, the Plaque index (Pl), the gingival index (GI), the Papillary Bleeding Index (PBI), 1977, and probing depth (PD) will be evaluated.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Probiotics, Traditional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDrug
In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges.
Traditional treatmentProcedure or surgery
In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Experimental | In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges. Receives: Drug: Probiotics |
| The control group without Probiotics | Active comparator | In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges. Receives: Procedure: Traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the plaque index
Assessment will be achieved using a gingival probe, according to Silness and Loe (1964). The criteria for plaque index are as follows:
- No plaque
- A film of plaque adheres to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after the application of the disclosing solution or by using a probe on the tooth surface.
- Moderate accumulation of soft deposits within the gingival pocket, or the tooth and the gingival margin, which can be seen with the naked eye.
- An abundance of soft matter within the gingival pocket and/or the tooth and gingival margin.
Measured: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
The change in the gingival index
Assessment will be achieved using a gingival probe, according to Silness and Loe (1964). The criteria for the gingival index are as follows:
- Normal gingiva.
- Mild inflammation: a slight change in color, slight edema, no bleeding on probing.
- Moderate inflammation: moderate glazing, redness, edema, hypertrophy, bleeding on probing.
- Severe inflammation: marked redness and hypertrophic ulceration, tendency to spontaneous bleeding.
Measured: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
The change in papillary bleeding index
Assessment will be achieved using a gingival probe, according to Muhlemann (1977).
- No bleeding.
- A single discreet bleeding point appears.
- Several isolated bleeding points or a single fine line of blood appear.
- The interdental triangle fills with blood shortly after probing.
- Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
Measured: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
The change in the probing depth
Assessment will be achieved using a gingival probe, according to Bowers (1964). It will be measured clinically as the distance from the free gingival margin to the gingival sulcus. The reading of PD ≤3 mm was considered normal, while any reading >3 mm was considered a gingival pocket
Measured: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Mar 2023
- Primary completion6 Aug 2023
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lana Hasan Albardwel, DDS, Principal investigator, Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus , Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641960
- Sponsor's protocol ID
- UDDS-Ortho-6-2024
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cerroni S, Pasquantonio G, Condo R, Cerroni L. Orthodontic Fixed Appliance and Periodontal Status: An Updated Systematic Review. Open Dent J. 2018 Sep 28;12:614-622. doi: 10.2174/1745017901814010614. eCollection 2018.
PubMed 30369970Contaldo M, Lucchese A, Lajolo C, Rupe C, Di Stasio D, Romano A, Petruzzi M, Serpico R. The Oral Microbiota Changes in Orthodontic Patients and Effects on Oral Health: An Overview. J Clin Med. 2021 Feb 16;10(4):780. doi: 10.3390/jcm10040780.
PubMed 33669186Agossa K, Dubar M, Lemaire G, Blaizot A, Catteau C, Bocquet E, Nawrocki L, Boyer E, Meuric V, Siepmann F. Effect of Lactobacillus reuteri on Gingival Inflammation and Composition of the Oral Microbiota in Patients Undergoing Treatment with Fixed Orthodontic Appliances: Study Protocol of a Randomized Control Trial. Pathogens. 2022 Jan 18;11(2):112. doi: 10.3390/pathogens11020112.
PubMed 35215057Freitas AO, Marquezan M, Nojima Mda C, Alviano DS, Maia LC. The influence of orthodontic fixed appliances on the oral microbiota: a systematic review. Dental Press J Orthod. 2014 Mar-Apr;19(2):46-55. doi: 10.1590/2176-9451.19.2.046-055.oar.
PubMed 24945514Santonocito S, Polizzi A. Oral Microbiota Changes during Orthodontic Treatment. Front Biosci (Elite Ed). 2022 Jul 27;14(3):19. doi: 10.31083/j.fbe1403019.
PubMed 36137992
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Probiotics on Oral Health During Adult Orthodontic Treatment With Fixed Appliances: A Two-arm Parallel-group Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06641960
- Acronym / sponsor ID
- UDDS-Ortho-6-2024
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 6 Aug 2023 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 15 Oct 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.
Fifty patients needing non-extraction-based metallic orthodontic treatment will be divided randomly into the probiotic group and the control group. In each group, they will brush their teeth regularly while receiving orthodontic treatment. Only the probiotic group will take probiotic tablets for six months.
Clinical parameters will be assessed before and during orthodontic treatment and after 3 and 6 months during treatment.
Detailed description
Each subject will be examined completely to ensure eligibility before enrolling in the study. The operator will then inform them about the study's aim and ask them to provide written informed consent. Patients will receive professional scaling, polishing, and oral hygiene instruction before the research starts.
Regarding the probiotic, (PRODENTIS) is commercially available in Sweden and the USA. Probiotics prepared by Bio-Gaia AB (Stockholm, Sweden). Each probiotic tablet contains two strains of probiotic lactic acid bacteria of human origin: L. reuteri DSM 17938 and L. reuteri ATCC (PTA 5289), each at a minimum of 1 × 108 CFU per lozenge. The tablets should be stored at a temperature below 25 ◦C. Dosage instructions will be prescribed per the manufacturer's recommendations at a preventive dosage of 1 lozenge/day (after dinner and teeth brushing).
Regarding the clinical parameters, the Plaque index (Pl), the gingival index (GI), the Papillary Bleeding Index (PBI), 1977, and probing depth (PD) will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Experimental | Drug: ProbioticsIn this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges. |
| The control group without Probiotics | Active comparator | Procedure: Traditional treatmentIn this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adult healthy male and female patients aged 18-25 years.
- Patients eligible for full arch upper and lower fixed labial orthodontic appliance treatment and molar band.
- Patients with malocclusion class I, II, or III without crowding on the anterior teeth.
- Permanent occlusion and existence of all the upper and lower teeth (except third molars).
- Good oral and periodontal health:
Key exclusion criteria (7 listed)
- Previous orthodontic treatment history.
- Patients with any systemic disorder that could influence periodontal conditions or response to treatment (such as hypertension, diabetes, or immunological disorders).
- Patients were on systemic drugs, i.e., antibiotics, hypertensives, analgesics, hormonal drugs, sedatives, and anti-seizure medication, within three months before the baseline examination.
- Patients who were allergic to ingredients of the probiotics lozenges.
- Those undergoing periodontal treatment within three months before the baseline examination.
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 |
|---|---|---|
| ProbioticsIn this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges. | Drug | Probiotics group |
| Traditional treatmentIn this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges. | Procedure or surgery | The control group without Probiotics |
Primary outcome
The change in the plaque index
Time frame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
Assessment will be achieved using a gingival probe, according to Silness and Loe (1964). The criteria for plaque index are as follows: 0. No plaque 1. A film of plaque adheres to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after the application of the disclosing solution or by using a probe on the tooth surface. 2. Moderate accumulation of soft deposits within the gingival pocket, or the tooth and the gingival margin, which can be seen with the naked eye. 3. An abundance of soft matter within the gingival pocket and/or the tooth and gingival margin.
The change in the gingival index
Time frame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
Assessment will be achieved using a gingival probe, according to Silness and Loe (1964). The criteria for the gingival index are as follows: 0. Normal gingiva. 1. Mild inflammation: a slight change in color, slight edema, no bleeding on probing. 2. Moderate inflammation: moderate glazing, redness, edema, hypertrophy, bleeding on probing. 3. Severe inflammation: marked redness and hypertrophic ulceration, tendency to spontaneous bleeding.
The change in papillary bleeding index
Time frame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
Assessment will be achieved using a gingival probe, according to Muhlemann (1977). 0. No bleeding. 1. A single discreet bleeding point appears. 2. Several isolated bleeding points or a single fine line of blood appear. 3. The interdental triangle fills with blood shortly after probing. 4. Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
The change in the probing depth
Time frame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
Assessment will be achieved using a gingival probe, according to Bowers (1964). It will be measured clinically as the distance from the free gingival margin to the gingival sulcus. The reading of PD ≤3 mm was considered normal, while any reading >3 mm was considered a gingival pocket
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 16 Oct 2024.
- Background: PubMed 30369970Cerroni S, Pasquantonio G, Condo R, Cerroni L. Orthodontic Fixed Appliance and Periodontal Status: An Updated Systematic Review. Open Dent J. 2018 Sep 28;12:614-622. doi: 10.2174/1745017901814010614. eCollection 2018.
- Background: PubMed 33669186Contaldo M, Lucchese A, Lajolo C, Rupe C, Di Stasio D, Romano A, Petruzzi M, Serpico R. The Oral Microbiota Changes in Orthodontic Patients and Effects on Oral Health: An Overview. J Clin Med. 2021 Feb 16;10(4):780. doi: 10.3390/jcm10040780.
- Background: PubMed 35215057Agossa K, Dubar M, Lemaire G, Blaizot A, Catteau C, Bocquet E, Nawrocki L, Boyer E, Meuric V, Siepmann F. Effect of Lactobacillus reuteri on Gingival Inflammation and Composition of the Oral Microbiota in Patients Undergoing Treatment with Fixed Orthodontic Appliances: Study Protocol of a Randomized Control Trial. Pathogens. 2022 Jan 18;11(2):112. doi: 10.3390/pathogens11020112.
- Background: PubMed 24945514Freitas AO, Marquezan M, Nojima Mda C, Alviano DS, Maia LC. The influence of orthodontic fixed appliances on the oral microbiota: a systematic review. Dental Press J Orthod. 2014 Mar-Apr;19(2):46-55. doi: 10.1590/2176-9451.19.2.046-055.oar.
- Background: PubMed 36137992Santonocito S, Polizzi A. Oral Microbiota Changes during Orthodontic Treatment. Front Biosci (Elite Ed). 2022 Jul 27;14(3):19. doi: 10.31083/j.fbe1403019.
- 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.
Lana Hasan Albardwel, DDS principal investigator
Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus , Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics and Traditional treatment in people with Orthodontic Appliance Complication, run by Damascus University at 1 site in Syria.
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 9 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 16 Oct 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 Syria. 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?
The change in the plaque index (time frame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months). The study lists 4 primary outcomes in all. 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 NCT06641960, which also lists 5 linked publications.
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 16 Oct 2024.