- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01811316
A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Massachusetts
-
Cambridge, Massachusetts, Stati Uniti, 02142
- The Forsyth Institute
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Willing and able to read, understand and sign an Informed Consent form.
- Good general health as evidenced by the medical history.
- Between 18 and 65 years of age.
- Male or female.
- Minimum of 20 teeth, excluding crowns and third molar teeth.
- Mean whole mouth Modified Gingival Index of greater-than or equal to 2.0 at baseline.
- Willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits.
- Willing to abstain from eating and drinking in the morning of visits, only drinking water is allowed.
- Willing to abstain from interdental cleaning, chewing gums, oral whitening, mouth rinse and tobacco products for the study duration.
- Able to understand and follow study directions.
- No known history of allergy to dairy products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
Exclusion Criteria
- Presence of orthodontic appliances.
- Intra-oral soft tissue lesions due to pathology or trauma
- Patients with aggressive periodontitis, acute necrotizing ulcerative gingivitis, or gross decay at discretion of PI.
- More than two sites with pocket depth >5mm and concomitant attachment loss of >2mm.
- Pregnant or lactating females or females of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
- Use of antibiotics within 3 months of enrollment
- History of drug use that is associated with gum overgrowth (i.e., Dilantin, nifedipine, etc)
- Chronic use of medication such as steroids, NSAIDs (more than 2-3 days/week), anti-coagulant medications, immunosuppressant medications or any other medications that in the opinion of the Investigator would interfere with the evaluation or confound interpretation of the study results. Use of low dose of acetylsalicylic acid (81 mg) is permitted.
- Unwilling to sign a confidentiality statement and/or return the test products.
- Medical condition which requires pre-medication prior to dental visits/procedures.
- Immune compromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- Current use of probiotics or probiotic containing food (i.e., yogurt)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Probiotics Lozenge (twice a day)
Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
|
|
Comparatore attivo: Probiotics Lozenge (once a day)
Subjects take their lozenge once a day, one lozenge at night after brushing.
|
|
Comparatore placebo: Placebo Lozenge (once a day)
Subjects take their lozenge once a day, one lozenge at night after brushing.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Modified Gingival Index (MGI)
Lasso di tempo: 4, 12 and 24 weeks
|
Modified Gingival Index (MGI) (Lobene, Weatherford et al. 1986) was measured on six gingival areas of all scorable teeth, using a scale of 0-4 as follows: Scores Criteria 0 Normal (absence of inflammation)
Whole mouth MGI scores were calculated by summing all scores and dividing by the number of examined scorable sites. |
4, 12 and 24 weeks
|
Change From Baseline in Bleeding on Probing (BOP)
Lasso di tempo: 4, 12 and 24 weeks
|
Bleeding on probing was assessed 30 seconds after probing.
A dichotomous scoring system was used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively.
BOP (%) is a percentage of sites BOP.
|
4, 12 and 24 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Plaque Index (PI)
Lasso di tempo: 4, 12 and 24 weeks
|
Plaque Index of Turesky Modification of Quigley-Hein (Turesky, Gilmore et al. 1970) (PI) was scored on all natural teeth (except third molars) after disclosing with erythrosine solution. Scores Criteria: 0 No plaque
|
4, 12 and 24 weeks
|
Change From Baseline in Probing Depth (PD)
Lasso di tempo: 4, 12 and 24 weeks
|
Periodontal pocket depth (PD) was determined with a periodontal probe at six sites per tooth rounded to the next lower whole mm.
|
4, 12 and 24 weeks
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Inflammatory Markers in Gingival Crevicular
Lasso di tempo: 15 days, 4, 12 and 24 weeks
|
Gingival Crevicular Fluid (GCF) samples will be analyzed for inflammatory cytokines/chemokines and matrix metalloproteases using multiplexing ELISA.
|
15 days, 4, 12 and 24 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Hatice Hasturk, DDS, PhD, The Forsyth Institute
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CLP-2013-1-23
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Probiotics
-
Pomeranian Medical University SzczecinCompletato