Probiotic Intervention After Surgical Removal of Mandibular Third Molars
Raktažodžiai
Santrauka
apibūdinimas
This was a single-centre, prospective, double-blind, randomized, placebo-controlled, parallel-group study to evaluate whether probiotic supplementation during 1 week after surgery reduced post-surgery complications compared to placebo.
Healthy subjects of both genders aged between 14 and 25 years who required the surgical removal of both mandibular 3rd molars were recruited from the department of Oral and Maxillofacial Surgery at the Foundation of Hospital de Nens de Barcelona (Children's Hospital of Barcelona).
Patients were randomly assigned to receive probiotic tablets containing a mixture of L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) or to receive placebo, twice a day for 7 days post surgery.
Patients were assessed by trained specialists for surgery-derived complications (fever, oral alveolitis, alveolar osteitis, trismus) in a follow-up visit 7 days after surgery. Patients also provided daily evaluations for pain, swelling and eating difficulties in a patient diary.
Datos
| Paskutinį kartą patikrinta: | 04/30/2020 |
| Pirmasis pateikimas: | 12/16/2019 |
| Numatytas registravimas pateiktas: | 12/16/2019 |
| Pirmas paskelbtas: | 12/17/2019 |
| Paskutinis atnaujinimas pateiktas: | 05/04/2020 |
| Paskutinis atnaujinimas paskelbtas: | 05/05/2020 |
| Faktinė studijų pradžios data: | 05/31/2016 |
| Numatoma pirminio užbaigimo data: | 03/31/2017 |
| Numatoma studijų užbaigimo data: | 04/30/2017 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: Probiotic
Other: Control
Procedure: Surgical removal of mandibular third molars at baseline
Drug: Ibuprofen
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: Probiotic Orodispersible tablets containing AB-DENTALAC probiotic formula. | Dietary Supplement: Probiotic Orodispersible tablets containing Lactobacillus plantarum [now Lactoplantibacillus plantarum] KABP051 (CECT7481) and Lactobacillus brevis [now Levilactobacillus brevis] KABP052 (CECT7480) as active ingredients, at a minimum dose of 5x10^8 cfu each, and sorbitol (E420) and guar gum (E412) as excipients, taken b.i.d. for 7 days. |
| Placebo Comparator: Control Orodispersible tablets without probiotic strains (excipients only). | Other: Control Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 14 Years Į 14 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - Otherwise healthy male and female undergoing surgical removal of both third mandibular molars. - Aged between 14 and 25 years. - Providing informed consent if 18yr and older, or parents/guardians providing informed consent otherwise Exclusion Criteria: - Subjects with gingival index (GI; according to Loe and Silness. 1963) or dental plaque index (PlI; according to Silness and Loe. 1964) above 2 in the CPI Community Periodontal Index) teeth subset. - Subjects having used probiotics or antibiotics within 30 days prior to study enrollment. - Tobacco use - Pregnant and breastfeeding women. - Known allergies to ingredients in study products. - Not willing to refrain from using mouthwashes during the study period |
Rezultatas
Pirminės rezultatų priemonės
1. Complications derived from surgical removal of both mandibular third molars [7 days]
Antrinės rezultatų priemonės
1. Post-surgical pain, patient-rated [Daily, for 7 days]
2. Post-surgical swelling, patient-rated [Daily, for 7 days]
3. Post-surgical eating difficulty, patient-rated [Daily, for 7 days]
