A Phase 3 interventional study of Probiotic Blend Chewable Tablet and Antibiotics in Periodontal Diseases and Smoking, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-24.
Sponsored by Dow University of Health Sciences · Phase 3, Interventional, and Treatment
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.
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.
855 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's enrollment of 66 is above the median of 45 across 546 interventional studies indexed under Periodontal Diseases.
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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.
Drug: Antibiotics
The probiotic group is provided with Lactobacillus-reuteri probiotics (2x10(8)CFU) twice daily after brushing for 30 days.
Drug: Probiotic Blend Chewable Tablet
Lactobacillus-reuteri probiotics were used as an experimental drug.
Also known as: Scaling and root debridement.
Amoxicillin capsules 500mg and metronidazole tablets 400mg antibiotics were used as an active comparator.
Also known as: Scaling and root debridement.
Change in Probing pocket depth
Probing pocket depth is recorded on six sites per tooth.
Time frame: At baseline.
Change in Probing pocket depth
Probing pocket depth is recorded on six sites per tooth.
Time frame: After 1-month.
Change in Probing pocket depth
Probing pocket depth is recorded on six sites per tooth.
Time frame: After 3-months.
Change in Clinical attachment level
Clinical attachment level is recorded on six sites per tooth.
Time frame: At baseline.
Change in Clinical attachment level
Clinical attachment level is recorded on six sites per tooth.
Time frame: After 1-month.
Change in Clinical attachment level
Clinical attachment level is recorded on six sites per tooth.
Time frame: 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.
Time frame: At baseline.
Change in Bleeding on probing
Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.
Time frame: 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.
Time frame: After 3-months.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 3-months.
Plan to share: Yes — The data will be available for sharing after 6-months of publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data will be available after the publication of the study for 1 year.
Access criteria: Contact the principal investigator through email.
Ran from Jul 2018 to primary completion in Apr 2019, 9 months.
Of 20 phase 3 interventional studies under Periodontal Diseases, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 23. This study's 9 months is above that.
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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