Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy
Primary Purpose
Periodontal Diseases, Smoking
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Probiotic Blend Chewable Tablet
Antibiotics
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Mehwish Ghazal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Antibiotics
Probiotics
Arm Description
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.
The probiotic group is provided with Lactobacillus-reuteri probiotics (2x10(8)CFU) twice daily after brushing for 30 days.
Outcomes
Primary Outcome Measures
Change in Probing pocket depth
Probing pocket depth is recorded on six sites per tooth.
Change in Probing pocket depth
Probing pocket depth is recorded on six sites per tooth.
Change in Probing pocket depth
Probing pocket depth is recorded on six sites per tooth.
Change in Clinical attachment level
Clinical attachment level is recorded on six sites per tooth.
Change in Clinical attachment level
Clinical attachment level is recorded on six sites per tooth.
Change in Clinical attachment level
Clinical attachment level is recorded on six sites per tooth.
Change in Bleeding on probing
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Change in Bleeding on probing
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Change in Bleeding on probing
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04209777
First Posted
December 18, 2019
Last Updated
December 20, 2019
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04209777
Brief Title
Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy
Official Title
Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy With Scaling and Root Debridement: a Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 8, 2018 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
May 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Smoking
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antibiotics
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Probiotics
Arm Type
Experimental
Arm Description
The probiotic group is provided with Lactobacillus-reuteri probiotics (2x10(8)CFU) twice daily after brushing for 30 days.
Intervention Type
Drug
Intervention Name(s)
Probiotic Blend Chewable Tablet
Other Intervention Name(s)
Scaling and root debridement.
Intervention Description
Lactobacillus-reuteri probiotics were used as an experimental drug.
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Other Intervention Name(s)
Scaling and root debridement.
Intervention Description
Amoxicillin capsules 500mg and metronidazole tablets 400mg antibiotics were used as an active comparator.
Primary Outcome Measure Information:
Title
Change in Probing pocket depth
Description
Probing pocket depth is recorded on six sites per tooth.
Time Frame
At baseline.
Title
Change in Probing pocket depth
Description
Probing pocket depth is recorded on six sites per tooth.
Time Frame
After 1-month.
Title
Change in Probing pocket depth
Description
Probing pocket depth is recorded on six sites per tooth.
Time Frame
After 3-months.
Title
Change in Clinical attachment level
Description
Clinical attachment level is recorded on six sites per tooth.
Time Frame
At baseline.
Title
Change in Clinical attachment level
Description
Clinical attachment level is recorded on six sites per tooth.
Time Frame
After 1-month.
Title
Change in Clinical attachment level
Description
Clinical attachment level is recorded on six sites per tooth.
Time Frame
After 3-months.
Title
Change in Bleeding on probing
Description
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Time Frame
At baseline.
Title
Change in Bleeding on probing
Description
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Time Frame
After 1-month.
Title
Change in Bleeding on probing
Description
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Time Frame
After 3-months.
Secondary Outcome Measure Information:
Title
Change in Plaque index
Description
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.
Time Frame
At baseline.
Title
Change in Plaque index
Description
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.
Time Frame
After 1-month.
Title
Change in Plaque index
Description
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.
Time Frame
After 3-months.
Title
Change in Gingival index
Description
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.
Time Frame
At baseline.
Title
Change in Gingival index
Description
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.
Time Frame
After 1-month.
Title
Change in Gingival index
Description
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.
Time Frame
After 3-months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahbaz Ahmed, BDS/FCPS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Mehwish Ghazal
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available for sharing after 6-months of publication.
IPD Sharing Time Frame
The data will be available after the publication of the study for 1 year.
IPD Sharing Access Criteria
Contact the principal investigator through email.
Citations:
PubMed Identifier
30663271
Citation
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.
Results Reference
result
PubMed Identifier
26944407
Citation
Morales 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 Reference
result
PubMed Identifier
30931588
Citation
Theodoro 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 Reference
result
PubMed Identifier
23176716
Citation
Vicario 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 Reference
result
PubMed Identifier
28678975
Citation
Assem 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 Reference
result
PubMed Identifier
31620939
Citation
Grusovin 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 Reference
result
PubMed Identifier
23253833
Citation
Albandar 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 Reference
result
PubMed Identifier
29364340
Citation
Morales 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 Reference
result
PubMed Identifier
29604177
Citation
Ikram 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.
Results Reference
result
Learn more about this trial
Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy
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