Periodontal DiseasesPhase 3NCT04209777
Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy
A Phase 3 study testing Probiotic Blend Chewable Tablet and Antibiotics in people with Periodontal Diseases and Smoking, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
It is a clinical trial conducted on smokers with chronic periodontitis in which the participants are divided into two groups and one group is provided with antibiotics while the other with probiotics as an adjunct to non-surgical therapy. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Smoking
- What is being tested?
- Probiotic Blend Chewable Tablet and Antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Jul 2018to 6 May 2019
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- systemically healthy males or females.
- at least 35 years of age with minimal 3 natural teeth in each quadrant excluding 3rd molar.
- previously untreated moderate to severe generalized chronic periodontitis
- were current smokers having ≥10 cigarettes /day.
Who cannot join
- having periodontal therapy within the past 6 months.
- have undergone antibiotics or long-term NSAIDS therapy within the past 6 months.
- have an allergy to penicillin and metronidazole.
- having either fixed or removable prosthesis.
- pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy With Scaling and Root Debridement: a Clinical Trial
It is a clinical trial conducted on smokers with chronic periodontitis in which the participants are divided into two groups and one group is provided with antibiotics while the other with probiotics as an adjunct to non-surgical therapy. The participants were assessed for change in probing pocket depths, attachment loss, bleeding on probing, plaque index and gingival index after 1-month and 3-month period.
Read the detailed description
Background:
Periodontal disease is a chronic inflammatory disease of the supporting structures of the tooth which includes periodontal ligament, cementum, and bone. Conventional periodontal therapy involves a non-surgical and surgical method for mechanical debridement of supragingival and subgingival sites to eliminate the pathogens and reduce inflammation of the periodontium. Smokers respond less to conventional therapy and require antibiotics for additional benefits. Where the use of antibiotics provides benefits to the host, the increasing proportion of developing antibiotic resistance are a major concern. The introduction of "Probiotics" as a treatment option is under special consideration. According to WHO, Probiotics are defined as viable micro-organisms which when delivered in an appropriate dose, provides health benefits. Lactobacillus-reuteri has been considered as a reliable option in regards to safety with no reported adverse effects, in the treatment of periodontitis as an adjunct to Scaling and Root Debridement.
Objectives:
The objective of the present study is to evaluate the clinical improvement of Lactobacillusreuteri Probiotics in comparison to a combination of amoxicillin and metronidazole antibiotics in smokers with moderate to severe chronic periodontitis after non-surgical scaling and root debridement.
Method:
A total number of 60 Smokers with moderate to severe chronic periodontitis were randomized into two groups after taking consent. Group 1 received amoxicillin and metronidazole for 7 days and placebo for Probiotics for 30 days. Group 2 was provided with 1 tablet of Lactobacillus-reuteri Probiotics (2x108CFU) twice daily after brushing for 30 days and a placebo for antibiotics for 7 days. At recruitment, scaling and root debridement were performed and change in pocket depth, attachment loss, gingival index, plaque index and bleeding on probing were recorded. The same outcomes were recorded again at 1 month and 3 months follow-up. Mean, standard deviation and confidence interval were reported using SPSS version-20.
- Conditions
- Periodontal Diseases, Smoking
- Being tested
- Probiotic Blend Chewable Tablet, Antibiotics
- Medical subject headings
- Periodontal Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Blend Chewable TabletDrug
Also called Scaling and root debridement.
Lactobacillus-reuteri probiotics were used as an experimental drug.
AntibioticsDrug
Also called Scaling and root debridement.
Amoxicillin capsules 500mg and metronidazole tablets 400mg antibiotics were used as an active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Active comparator | The antibiotic group is provided with amoxicillin capsules 500mg and metronidazole tablets 400mg three times a day for 7 days along with the placebo of probiotics twice daily for 30 days. Receives: Drug: Antibiotics |
| Probiotics | Experimental | The probiotic group is provided with Lactobacillus-reuteri probiotics (2x10(8)CFU) twice daily after brushing for 30 days. Receives: Drug: Probiotic Blend Chewable Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing pocket depth
Probing pocket depth is recorded on six sites per tooth.
Measured: At baseline.
Change in Probing pocket depth
Probing pocket depth is recorded on six sites per tooth.
Measured: After 1-month.
Change in Probing pocket depth
Probing pocket depth is recorded on six sites per tooth.
Measured: After 3-months.
Change in Clinical attachment level
Clinical attachment level is recorded on six sites per tooth.
Measured: At baseline.
Change in Clinical attachment level
Clinical attachment level is recorded on six sites per tooth.
Measured: After 1-month.
Change in Clinical attachment level
Clinical attachment level is recorded on six sites per tooth.
Measured: After 3-months.
Change in Bleeding on probing
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Measured: At baseline.
Change in Bleeding on probing
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Measured: After 1-month.
Change in Bleeding on probing
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Measured: After 3-months.
Secondary outcomes (6)
Change in Plaque index
Plaque index is recorded to check deposits on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. all the six sites of each tooth are examined.
0= No plaque; 1= A film of plaque adhering to the free gingival margin and adjacent area of the tooth; 2= Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye; 3= Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: At baseline.
Change in Plaque index
Plaque index is recorded to check deposits on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. all the six sites of each tooth are examined.
0= No plaque; 1= A film of plaque adhering to the free gingival margin and adjacent area of the tooth; 2= Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye; 3= Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: After 1-month.
Change in Plaque index
Plaque index is recorded to check deposits on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. all the six sites of each tooth are examined.
0= No plaque; 1= A film of plaque adhering to the free gingival margin and adjacent area of the tooth; 2= Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye; 3= Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: After 3-months.
Change in Gingival index
Gingival index is recorded on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. mesio-buccal, disto-buccal, buccal/facial margin and lingual gingival margin is assessed.
0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
Measured: At baseline.
Change in Gingival index
Gingival index is recorded on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. mesio-buccal, disto-buccal, buccal/facial margin and lingual gingival margin is assessed.
0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
Measured: After 1-month.
Change in Gingival index
Gingival index is recorded on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. mesio-buccal, disto-buccal, buccal/facial margin and lingual gingival margin is assessed.
0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
Measured: After 3-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start8 Jul 2018
- Primary completion16 Apr 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehwish Ghazal, Dow University of Health Sciences
- Investigators
- Shahbaz Ahmed, BDS/FCPS, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209777
- Sponsor's protocol ID
- MGhazal
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available for sharing after 6-months of publication.
Publications
Ikram S, Hassan N, Baig S, Borges KJJ, Raffat MA, Akram Z. Effect of local probiotic (Lactobacillus reuteri) vs systemic antibiotic therapy as an adjunct to non-surgical periodontal treatment in chronic periodontitis. J Investig Clin Dent. 2019 May;10(2):e12393. doi: 10.1111/jicd.12393. Epub 2019 Jan 20.
PubMed 30663271Morales A, Carvajal P, Silva N, Hernandez M, Godoy C, Rodriguez G, Cabello R, Garcia-Sesnich J, Hoare A, Diaz PI, Gamonal J. Clinical Effects of Lactobacillus rhamnosus in Non-Surgical Treatment of Chronic Periodontitis: A Randomized Placebo-Controlled Trial With 1-Year Follow-Up. J Periodontol. 2016 Aug;87(8):944-52. doi: 10.1902/jop.2016.150665. Epub 2016 Mar 4.
PubMed 26944407Theodoro LH, Claudio MM, Nuernberg MAA, Miessi DMJ, Batista JA, Duque C, Garcia VG. Effects of Lactobacillus reuteri as an adjunct to the treatment of periodontitis in smokers: randomised clinical trial. Benef Microbes. 2019 Apr 19;10(4):375-384. doi: 10.3920/BM2018.0150. Epub 2019 Apr 1.
PubMed 30931588Vicario M, Santos A, Violant D, Nart J, Giner L. Clinical changes in periodontal subjects with the probiotic Lactobacillus reuteri Prodentis: a preliminary randomized clinical trial. Acta Odontol Scand. 2013 May-Jul;71(3-4):813-9. doi: 10.3109/00016357.2012.734404. Epub 2012 Nov 26.
PubMed 23176716Assem NZ, Alves MLF, Lopes AB, Gualberto EC Junior, Garcia VG, Theodoro LH. Antibiotic therapy as an adjunct to scaling and root planing in smokers: a systematic review and meta-analysis. Braz Oral Res. 2017 Jul 3;31:e67. doi: 10.1590/1807-3107BOR-2017.vol31.0067.
PubMed 28678975Grusovin MG, Bossini S, Calza S, Cappa V, Garzetti G, Scotti E, Gherlone EF, Mensi M. Clinical efficacy of Lactobacillus reuteri-containing lozenges in the supportive therapy of generalized periodontitis stage III and IV, grade C: 1-year results of a double-blind randomized placebo-controlled pilot study. Clin Oral Investig. 2020 Jun;24(6):2015-2024. doi: 10.1007/s00784-019-03065-x. Epub 2019 Oct 16.
PubMed 31620939Albandar JM. Adjunctive antibiotics with nonsurgical periodontal therapy improve the clinical outcome of chronic periodontitis in current smokers. J Evid Based Dent Pract. 2012 Sep;12(3 Suppl):63-6. doi: 10.1016/S1532-3382(12)70015-5.
PubMed 23253833Morales A, Gandolfo A, Bravo J, Carvajal P, Silva N, Godoy C, Garcia-Sesnich J, Hoare A, Diaz P, Gamonal J. Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up. J Appl Oral Sci. 2018 Jan 18;26:e20170075. doi: 10.1590/1678-7757-2017-0075.
PubMed 29364340Ikram S, Hassan N, Raffat MA, Mirza S, Akram Z. Systematic review and meta-analysis of double-blind, placebo-controlled, randomized clinical trials using probiotics in chronic periodontitis. J Investig Clin Dent. 2018 Aug;9(3):e12338. doi: 10.1111/jicd.12338. Epub 2018 Mar 31.
PubMed 29604177
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy With Scaling and Root Debridement: a Clinical Trial
- ClinicalTrials.gov ID
- NCT04209777
- Acronym / sponsor ID
- MGhazal
- Conditions
- Periodontal Diseases, Smoking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 8 Jul 2018 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 24 Dec 2019 (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.
It is a clinical trial conducted on smokers with chronic periodontitis in which the participants are divided into two groups and one group is provided with antibiotics while the other with probiotics as an adjunct to non-surgical therapy. The participants were assessed for change in probing pocket depths, attachment loss, bleeding on probing, plaque index and gingival index after 1-month and 3-month period.
Detailed description
Background:
Periodontal disease is a chronic inflammatory disease of the supporting structures of the tooth which includes periodontal ligament, cementum, and bone. Conventional periodontal therapy involves a non-surgical and surgical method for mechanical debridement of supragingival and subgingival sites to eliminate the pathogens and reduce inflammation of the periodontium. Smokers respond less to conventional therapy and require antibiotics for additional benefits. Where the use of antibiotics provides benefits to the host, the increasing proportion of developing antibiotic resistance are a major concern. The introduction of "Probiotics" as a treatment option is under special consideration. According to WHO, Probiotics are defined as viable micro-organisms which when delivered in an appropriate dose, provides health benefits. Lactobacillus-reuteri has been considered as a reliable option in regards to safety with no reported adverse effects, in the treatment of periodontitis as an adjunct to Scaling and Root Debridement.
Objectives:
The objective of the present study is to evaluate the clinical improvement of Lactobacillusreuteri Probiotics in comparison to a combination of amoxicillin and metronidazole antibiotics in smokers with moderate to severe chronic periodontitis after non-surgical scaling and root debridement.
Method:
A total number of 60 Smokers with moderate to severe chronic periodontitis were randomized into two groups after taking consent. Group 1 received amoxicillin and metronidazole for 7 days and placebo for Probiotics for 30 days. Group 2 was provided with 1 tablet of Lactobacillus-reuteri Probiotics (2x108CFU) twice daily after brushing for 30 days and a placebo for antibiotics for 7 days. At recruitment, scaling and root debridement were performed and change in pocket depth, attachment loss, gingival index, plaque index and bleeding on probing were recorded. The same outcomes were recorded again at 1 month and 3 months follow-up. Mean, standard deviation and confidence interval were reported using SPSS version-20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Active comparator | Drug: AntibioticsThe antibiotic group is provided with amoxicillin capsules 500mg and metronidazole tablets 400mg three times a day for 7 days along with the placebo of probiotics twice daily for 30 days. |
| Probiotics | Experimental | Drug: Probiotic Blend Chewable TabletThe probiotic group is provided with Lactobacillus-reuteri probiotics (2x10(8)CFU) twice daily after brushing for 30 days. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- systemically healthy males or females.
- at least 35 years of age with minimal 3 natural teeth in each quadrant excluding 3rd molar.
- previously untreated moderate to severe generalized chronic periodontitis
- were current smokers having ≥10 cigarettes /day.
Key exclusion criteria (5 listed)
- having periodontal therapy within the past 6 months.
- have undergone antibiotics or long-term NSAIDS therapy within the past 6 months.
- have an allergy to penicillin and metronidazole.
- having either fixed or removable prosthesis.
- pregnant or nursing females.
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 Blend Chewable TabletAlso: Scaling and root debridement.Lactobacillus-reuteri probiotics were used as an experimental drug. | Drug | Probiotics |
| AntibioticsAlso: Scaling and root debridement.Amoxicillin capsules 500mg and metronidazole tablets 400mg antibiotics were used as an active comparator. | Drug | Antibiotics |
Primary outcome
Change in Probing pocket depth
Time frame: At baseline.
Probing pocket depth is recorded on six sites per tooth.
Change in Probing pocket depth
Time frame: After 1-month.
Probing pocket depth is recorded on six sites per tooth.
Change in Probing pocket depth
Time frame: After 3-months.
Probing pocket depth is recorded on six sites per tooth.
Change in Clinical attachment level
Time frame: At baseline.
Clinical attachment level is recorded on six sites per tooth.
Change in Clinical attachment level
Time frame: After 1-month.
Clinical attachment level is recorded on six sites per tooth.
Change in Clinical attachment level
Time frame: After 3-months.
Clinical attachment level is recorded on six sites per tooth.
Change in Bleeding on probing
Time frame: At baseline.
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Change in Bleeding on probing
Time frame: After 1-month.
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Change in Bleeding on probing
Time frame: After 3-months.
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
6 secondary outcomes
Change in Plaque index
Time frame: At baseline.
Change in Plaque index
Time frame: After 1-month.
Change in Plaque index
Time frame: After 3-months.
Change in Gingival index
Time frame: At baseline.
Change in Gingival index
Time frame: After 1-month.
Change in Gingival index
Time frame: After 3-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 24 Dec 2019.
- Results publication: PubMed 30663271Ikram S, Hassan N, Baig S, Borges KJJ, Raffat MA, Akram Z. Effect of local probiotic (Lactobacillus reuteri) vs systemic antibiotic therapy as an adjunct to non-surgical periodontal treatment in chronic periodontitis. J Investig Clin Dent. 2019 May;10(2):e12393. doi: 10.1111/jicd.12393. Epub 2019 Jan 20.
- Results publication: PubMed 26944407Morales A, Carvajal P, Silva N, Hernandez M, Godoy C, Rodriguez G, Cabello R, Garcia-Sesnich J, Hoare A, Diaz PI, Gamonal J. Clinical Effects of Lactobacillus rhamnosus in Non-Surgical Treatment of Chronic Periodontitis: A Randomized Placebo-Controlled Trial With 1-Year Follow-Up. J Periodontol. 2016 Aug;87(8):944-52. doi: 10.1902/jop.2016.150665. Epub 2016 Mar 4.
- Results publication: PubMed 30931588Theodoro LH, Claudio MM, Nuernberg MAA, Miessi DMJ, Batista JA, Duque C, Garcia VG. Effects of Lactobacillus reuteri as an adjunct to the treatment of periodontitis in smokers: randomised clinical trial. Benef Microbes. 2019 Apr 19;10(4):375-384. doi: 10.3920/BM2018.0150. Epub 2019 Apr 1.
- Results publication: PubMed 23176716Vicario M, Santos A, Violant D, Nart J, Giner L. Clinical changes in periodontal subjects with the probiotic Lactobacillus reuteri Prodentis: a preliminary randomized clinical trial. Acta Odontol Scand. 2013 May-Jul;71(3-4):813-9. doi: 10.3109/00016357.2012.734404. Epub 2012 Nov 26.
- Results publication: PubMed 28678975Assem NZ, Alves MLF, Lopes AB, Gualberto EC Junior, Garcia VG, Theodoro LH. Antibiotic therapy as an adjunct to scaling and root planing in smokers: a systematic review and meta-analysis. Braz Oral Res. 2017 Jul 3;31:e67. doi: 10.1590/1807-3107BOR-2017.vol31.0067.
- Results publication: PubMed 31620939Grusovin MG, Bossini S, Calza S, Cappa V, Garzetti G, Scotti E, Gherlone EF, Mensi M. Clinical efficacy of Lactobacillus reuteri-containing lozenges in the supportive therapy of generalized periodontitis stage III and IV, grade C: 1-year results of a double-blind randomized placebo-controlled pilot study. Clin Oral Investig. 2020 Jun;24(6):2015-2024. doi: 10.1007/s00784-019-03065-x. Epub 2019 Oct 16.
- Results publication: PubMed 23253833Albandar JM. Adjunctive antibiotics with nonsurgical periodontal therapy improve the clinical outcome of chronic periodontitis in current smokers. J Evid Based Dent Pract. 2012 Sep;12(3 Suppl):63-6. doi: 10.1016/S1532-3382(12)70015-5.
- Results publication: PubMed 29364340Morales A, Gandolfo A, Bravo J, Carvajal P, Silva N, Godoy C, Garcia-Sesnich J, Hoare A, Diaz P, Gamonal J. Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up. J Appl Oral Sci. 2018 Jan 18;26:e20170075. doi: 10.1590/1678-7757-2017-0075.
- Results publication: PubMed 29604177Ikram S, Hassan N, Raffat MA, Mirza S, Akram Z. Systematic review and meta-analysis of double-blind, placebo-controlled, randomized clinical trials using probiotics in chronic periodontitis. J Investig Clin Dent. 2018 Aug;9(3):e12338. doi: 10.1111/jicd.12338. Epub 2018 Mar 31.
- Individual participant dataSharing planned: Yes. The data will be available for sharing after 6-months of publication.
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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.
Shahbaz Ahmed, BDS/FCPS study director
Dow University of Health Sciences
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 Blend Chewable Tablet and Antibiotics in people with Periodontal Diseases and Smoking, run by Dow University of Health Sciences 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 4 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 24 Dec 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.
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?
Change in Probing pocket depth (time frame: At baseline.). The study lists 9 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 NCT04209777, which also lists 9 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 24 Dec 2019.