Adjunctive Probiotics in Chronic Periodontitis
10. marts 2019 opdateret af: Sana Ikram, MPhil Trainee, Ziauddin Hospital
Effect of Probiotic Along With Scaling and Root Planing in the Treatment of Chronic Periodontitis
This study will assess clinical and microbiological efficacy of probiotics and antibiotics in patients of chronic periodontitis as an adjunctive to scaling and root planing (SRP) in reducing bacterial count and in improving clinical periodontal parameters over the period of 12 weeks.Also the comparison between these adjunctives will be made for clinical assessment clinical periodontal parameters will be taken .these
parameters plaque index (PI), gingival index (GI), clinical attachment loss (CAL) and pocket probing depth (PPD) for microbiological assessment plaque sample will be taken, DNA will be extracted and then sample will be processed through quantitative polymerase chain reaction (qPCR) for quantitative analysis of bacterial count of porphyromonas gingivalis.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
In this clinical trial total 60 participants of clinically diagnosed chronic periodontitis will be recruited after taking a written consent for their approval.
Participants will be divided into 3 groups A, B and C through the process of randomization using a method of opaque sealed envelopes.
A research assistant will be hired for the purpose of randomization and allocation concealment.
All participants will be asked to pick an opaque envelope containing the details of treatment products.
After randomization plaque sample will be obtained from the depth of periodontal pockets and all the clinical periodontal parameters will be recorded in every participant.
Then all the participants will undergo SRP.
After SRP group A will be given antibiotics Amoxicillin 500 milligrams (mg) for 3 times a day (TDS) and Metronidazole 400 milligrams (mg) for twice a day (BD) for 5 days.
Group B will be given probiotics lactobacillus reuteri 1.2 billion colony forming unit (CFU) sachets twice daily for swallowing with water for 12 weeks.
Group C will be given lactobacillus sachets of same amount and participant will be asked to mix it with little amount of water and apply it on teeth with the toothbrush twice daily after brushing with standard tooth paste for 12 weeks.
Patients will be recalled at the interval of 3, 6, 9 and 12 weeks for the recording of clinical periodontal parameters.
After completion of trial plaque sample will be taken again from every participant and will be processed through qPCR to check bacterial count of porphyromonas gingivalis before and after treatment.
Whereas comparison between clinical periodontal parameters will be made at the interval of 0, 3, 6, 9, 12 weeks.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75600
- Ziauddin Dental College
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with clinically diagnosed chronic periodontitis with a pocket depth of ≥4mm.
- Patients with age ≥30 years.
Exclusion Criteria:
- Handicapped patients who are physically or mentally unable to maintain their oral hygiene.
- Pregnant and lactating females.
- Patients with habits of smoking, chewing tobacco and alcohol consumption.
- Patients on local or systemic antibiotic treatment.
- Patients with any systemic diseases.
- Patients with the history of any periodontal therapy within last 6 months.
- Patients undergoing orthodontic treatment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Local Probiotics
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks
|
Locally delivered Lactobacillus reuteri 1.2 CFU per gram
|
|
Eksperimentel: Systemic Probiotics
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks
|
Systemically administered Lactobacillus reuteri 1.2 CFU per gram
|
|
Aktiv komparator: Systemic Antibiotics
Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days
|
Systemically administered Amoxil 500 mg thrice daily
Systemically administered Metronidazole 400 mg twice daily
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in periodontal pocket depth (PPD)
Tidsramme: Baseline, 3, 6, 9 and 12 weeks
|
It is the distance from tip of free gingival margin to the base of pocket
|
Baseline, 3, 6, 9 and 12 weeks
|
|
Change in clinical attachment level (CAL)
Tidsramme: Baseline, 3, 6, 9 and 12 weeks
|
It is the distance from cementoenamel junction to the base of the pocket around the tooth
|
Baseline, 3, 6, 9 and 12 weeks
|
|
Change in bacterial load of Porphyromonas gingivalis
Tidsramme: Baseline and 12 weeks after completion of trial
|
Bacterial count or the quantity of porphyromonas gingivalis in the sample
|
Baseline and 12 weeks after completion of trial
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the Plaque index (PI)
Tidsramme: Baseline, 3, 6, 9 and 12 weeks
|
How much surface of tooth is covered by the plaque will be recorded.
|
Baseline, 3, 6, 9 and 12 weeks
|
|
Change in Gingival index (GI)
Tidsramme: Baseline, 3, 6, 9 and 12 weeks
|
Gingival color texture and inflammation will be recorded.
|
Baseline, 3, 6, 9 and 12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2017
Primær færdiggørelse (Faktiske)
1. september 2018
Studieafslutning (Faktiske)
1. oktober 2018
Datoer for studieregistrering
Først indsendt
3. april 2018
Først indsendt, der opfyldte QC-kriterier
13. april 2018
Først opslået (Faktiske)
17. april 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. marts 2019
Sidst verificeret
1. marts 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0220817SIOB
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .