Topical antimicrobial in supportive periodontal therapy Oral Health
Conditions
Interventions
Study design
This study is conducted as a triple-blind randomized placebo-controlled clinical trial of 12 months with a parallel design of three independent groups, with a 1:1:1 allocation ratio. The
Sponsors
Regedent (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 20-80 years 2. Treated periodontitis patients, that underwent supportive periodontal treatment for a minimum period of 6 months 3. At least 4 non-adjacent sites with PPDs =4 mm with BOP or PPDs >5 mm, but not deeper than 8 mm, with or without BOP, according to the criteria for the need of retreatment in SPT (rate of healing) (Tonetti, Lang & Cortellini 2012); the sites should not be associated with affected furcations, in third molars and in teeth severely malpositioned teeth. Ideally, the teeth should be in different quadrants 4. The teeth considered for assessment should be vital or should have an adequate root canal treatment 5. Compliant patients (mean BOP <25%, PCR <25%) 6. Patients who underwent systematic periodontal treatment in the same private practice where the study is conducted and have been documented regarding the periodontal evaluations, radiographs 7. Patients willing to provide written informed consent 8. Patients able to comply with 12-month study follow-up
Exclusion criteria
Exclusion criteria: 1. Known allergy or adverse reactions to hypochlorite 2. Clinically relevant psychological disorders 3. Alcohol abuse 4. Known HIV infection 5. Self-reported diabetes mellitus 6. Locally or systemic administration of antibiotics in the last 3 months 7. Pregnancy, breastfeeding If progression of periodontal destruction was observed or if adverse reactions to the test product were reported, the subject was removed from the study. Progression of periodontal destruction was defined as attachment loss > 2mm or an increase of PPD >2 mm between subsequent evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At baseline and 3-, 6-, 9- and 12-month re-evaluations the following are recorded using six sites per tooth by the same investigator: 1. Periodontal pocket depths (PPDs) 2. Full-mouth plaque scores (FMPS) 3. Full-mouth bleeding scores (FMBs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological samples will be collected from teeth with the deepest PPD recorded at the initial evaluation and 12-months to detect the presence of bacteria: Aggregatibacter actinomycetemcomitans (A.a.), Porphyromonas gingivalis (P.g.), Prevotella intermedia (P.i.), Tannerella forsythia (T.f.) and Treponema denticola (T.d.) measured using a molecular genetic analysis. | — |
Countries
Romania
Contacts
Public ContactViorelia Radulescu
Outcome results
None listed