First-in-man Study of Adult Patients Suffered From Alveolar Osteitis Treated Using Stomatological Tamponade Contipro

• Status: Completed
• Trial end date: 2016-02-12
• Target enrollment: 0
• Participant gender: All

Summary

Alveolar Osteitis (AO) is a complication following extraction of a tooth. AO manifests by localized pain in and around the extraction site where the postoperative blood clot has been disintegrated. The aim of this study was to determinate if there are any concerns of use of a pharmacological drug composed of an octenidine and lyophilized hyaluronic acid in a treatment of AO.

The tested drug is a sponge-like material composed solely of fully absorbable medicaments. It was designed to serve as non-toxic, slow-dissolving antiseptic which adheres to mucosa and so obturate the wound. The treatment was considered effective when the pain subsided to < 20mm VAS in < 8 days of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Contipro Pharma a.s.
• Treatments: Octenidine

Criteria

Inclusion Criteria:

• Patient with diagnosed alveolar osteitis

• Minimal age limit 18 years

• Patient capable to fully understand and comply with the requirements of the study

Exclusion Criteria:

• Patient younger than 18 years

• Pregnant or lactant woman

• Patient diagnosed with cancer

• Patient with a history of radiotherapy in the head and neck area

• Patient undergone bisphosphonate treatment within the last two years

• Patient who had been given antibiotics less than two weeks prior the AO onset

• Patient with hypersensitivity or allergy to any substances contained in the tested drug

• Patient who smokes more than 10 cigarettes per day