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

NCT04091399 | Completed Phase 2

• 1 other identifier: PT-ST-1_12-14
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Alveolar Osteitis

Keywords

first-man-study; alveolitis sicca dolorosa; alveolar osteitis; alveolalgia; sodium hyaluronate; octenidine hydrochlorid; clinical study

Outcome Measures

Primary Outcomes (1)

• The number of patients with treated related adverse effects objectively evaluated by examiners

  The prevalence of potential treatment-relatived adverse effect evaluated by dentists in follow-up examinations

  7 days/per patient

Secondary Outcomes (1)

• Pain change assessed by the VAS scale according to subjective evaluation by patients

  7 days/per patient

Other Outcomes (1)

• Extraction wound healing assessed by objectively evaluation of examiners

  7 days/per patient

Study Arms (1)

Patient cohort

EXPERIMENTAL

Patients suffered from alveolar osteitis and treated using a Stomatological tamponade Contipro, composed of the Hyaluronic acid and Octenidine dihydrochloride. Firstly, the extraction wound had been irrigated with 2 ml of 3% solution of H2O2 to disinfect the site and then flushed by 2 ml of Aqua pro injectione to clear any remaining debris. After, the tested drug was applied into the extraction wound. This procedure was repeated on a daily basis for a maximum of 7 days or until the pain subsided below 20 mm and remained there for at least 2 days.

Drug: Stamatological tamponade Contipro

Interventions

Stamatological tamponade Contipro DRUG

The drug is composed from the Hyaluronic acid and Octenidine dihydrochloride. It is designed to perform comparatively in pain alleviation and to promote healing of the alveolar osteitis while avoiding the side effects.

Patient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with diagnosed alveolar osteitis
• Minimal age limit 18 years
• Patient capable to fully understand and comply with the requirements of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Contipro Pharma a.s.: lead

Study Sites (11)

IchtysDent s.r.o

Brno, 60200, Czechia

Location

University Hospital Brno, Clinic of Oral, Maxillary and Facial Surgery

Brno, 62500, Czechia

Location

Prouzovi s.r.o.

Dvůr Králové nad Labem, 54401, Czechia

Location

University Hospital Hradec Králové, Department of Dentistry

Hradec Králové, 50005, Czechia

Location

Dentine s.r.o.

Jičín, 50601, Czechia

Location

FSmile s.r.o.

Opočno, 51773, Czechia

Location

Dentpra

Pardubice, 53002, Czechia

Location

Mojmír Strnad

Pardubice, 53002, Czechia

Location

MEDIKAP

Pardubice, 53009, Czechia

Location

DV Dent s.r.o.

Roudnice nad Labem, 41301, Czechia

Location

Enta Dent s.r.o

Ústí nad Labem, 400 01, Czechia

Location

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jakub Suchánek, MUDr.

  University Hospital Hradec Králové

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Collection personal data of patients suffered from alveolar osteotis 2. Patient cohort selection according inclusion and exlusion criteria 3. Extraction wound examination and characteriyation of a dry socket 4. Treatment of alveolar osteoitis using a tested drug 5. Extraction wound healing process and its evaluation 6. Data analysis

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 16, 2019
• Study Start: September 11, 2015
• Primary Completion: February 12, 2016
• Study Completion: February 12, 2016
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (11)