Reduction of residual and/or recurrent spaces or openings surrounding the teeth under the gum line using a sodium hypochlorite gel after completion of gum treatment

Not Applicable

Completed

• Conditions: Topical antimicrobial in supportive periodontal therapy; Oral Health

• Registration Number: ISRCTN11387188
• Lead Sponsor: Regedent (Switzerland)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35829773/ (added 14/07/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-09-01
• Study Start: 2021-12-09
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 85

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified