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

Primary Purpose

Alveolar Osteitis

Status
Completed
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
Stamatological tamponade Contipro
Sponsored by
Contipro Pharma a.s.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Osteitis focused on measuring first-man-study, alveolitis sicca dolorosa, alveolar osteitis, alveolalgia, sodium hyaluronate, octenidine hydrochlorid, clinical study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IchtysDent s.r.o
  • University Hospital Brno, Clinic of Oral, Maxillary and Facial Surgery
  • Prouzovi s.r.o.
  • University Hospital Hradec Králové, Department of Dentistry
  • Dentine s.r.o.
  • FSmile s.r.o.
  • Dentpra
  • Mojmír Strnad
  • MEDIKAP
  • DV Dent s.r.o.
  • Enta Dent s.r.o

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain change assessed by the VAS scale according to subjective evaluation by patients
Pain change was assessed by the VAS scale. Pain relief associated with treatment was determinated as drop on the VAS scale below 20 mm

Full Information

First Posted
September 8, 2019
Last Updated
September 13, 2019
Sponsor
Contipro Pharma a.s.
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1. Study Identification

Unique Protocol Identification Number
NCT04091399
Brief Title
First-in-man Study of Adult Patients Suffered From Alveolar Osteitis Treated Using Stomatological Tamponade Contipro
Official Title
Multi-centre, Open-label, First-in-man Study of Adult Patients Suffered From Alveolar Osteitis Treated Using Stomatological Tamponade Contipro
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2015 (Actual)
Primary Completion Date
February 12, 2016 (Actual)
Study Completion Date
February 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contipro Pharma a.s.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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 AO incidence is reportedly conditioned by multiple risk factors including trauma/difficult extraction, smoking, acute inflammation of periodontal tissues (e.g. dentitio difficilis) prior to extraction. The use of oral contraceptives results in about 10 times higher incidence of AO. Furthermore, secondary contributing risk factors include age, flap design, local anesthetic containing vasoconstrictor, and bone/root debris left in the extraction wound. The drug tested in this study was composed from the Hyaluronic acid (HA) and Octenidine dihydrochloride (ODC). It was designed to perform comparatively in pain alleviation and to promote healing while avoiding the side effects. The aim of this clinical study was to determinate if there are any concerns of use a pharmacological drug composed of ODC and HA in treatment of AO. The drug was designed to fulfill the following criteria: to disinfect the wound (provided by ODC), attach to the mucosa (HA), obturate the wound (HA), be stable in the presence of saliva (HA), be fully absorbable (ODC, HA), enhance healing process (HA), be non-allergic and have analgesic effect (ODC, HA). The sponge-like pharmacological drug is a lyophilized water solution of ODC, HA, stabilized with calcium chloride; as such it is fully dissoluble, has antiseptic properties and is malleable. The drug was manufactured by Contipro Pharma a.s. (Czech Republic). The study was designed as a multi-center, open-label, first-in-men study and was approved by the ethical committee of the University Hospital Hradec Králové. Upon the study initiation, the study subjects' extraction wounds were examined and described by the medical professional and the subjects' perceived-pain self-evaluation base data was recorded. The perceived pain was recorded on 0-100 mm VAS. Afterwards, the treatment was introduced. Firstly, the 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. The treatment was considered effective when the pain subsided to < 20mm VAS in < 8 days of treatment. Descriptive statistics were provided for each of the criteria using the following values: 1) for continuous data: mean, standard deviation (SD), median, lower/upper quartile, minimum and maximum values, 2) for qualitative data: absolute count and percentages. Hypotheses are tested at standard cutoff α = 0.05. A descriptive analysis approach (including frequency tables) was used to assess clinical management, clinical outcomes and healthcare resources used. When appropriate two-sided 95% confidence interval was obtained for population characteristics of a variable. All calculations and summaries were produced using R version 3.2.3 (R Core Team, Austria).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Osteitis
Keywords
first-man-study, alveolitis sicca dolorosa, alveolar osteitis, alveolalgia, sodium hyaluronate, octenidine hydrochlorid, clinical study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Collection personal data of patients suffered from alveolar osteotis Patient cohort selection according inclusion and exlusion criteria Extraction wound examination and characteriyation of a dry socket Treatment of alveolar osteoitis using a tested drug Extraction wound healing process and its evaluation Data analysis
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Stamatological tamponade Contipro
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of patients with treated related adverse effects objectively evaluated by examiners
Description
The prevalence of potential treatment-relatived adverse effect evaluated by dentists in follow-up examinations
Time Frame
7 days/per patient
Secondary Outcome Measure Information:
Title
Pain change assessed by the VAS scale according to subjective evaluation by patients
Description
Pain change was assessed by the VAS scale. Pain relief associated with treatment was determinated as drop on the VAS scale below 20 mm
Time Frame
7 days/per patient
Other Pre-specified Outcome Measures:
Title
Extraction wound healing assessed by objectively evaluation of examiners
Description
Examinars evaluated the extraction wound healing as a change of inflammation of the impacted alveolae on scale 0 - 5 (0 - no inflammation, 5 - persistant inflammation).
Time Frame
7 days/per patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakub Suchánek, MUDr.
Organizational Affiliation
University Hospital Hradec Králové
Official's Role
Principal Investigator
Facility Information:
Facility Name
IchtysDent s.r.o
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
University Hospital Brno, Clinic of Oral, Maxillary and Facial Surgery
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Prouzovi s.r.o.
City
Dvůr Králové Nad Labem
ZIP/Postal Code
54401
Country
Czechia
Facility Name
University Hospital Hradec Králové, Department of Dentistry
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Dentine s.r.o.
City
Jičín
ZIP/Postal Code
50601
Country
Czechia
Facility Name
FSmile s.r.o.
City
Opočno
ZIP/Postal Code
51773
Country
Czechia
Facility Name
Dentpra
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
Mojmír Strnad
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
MEDIKAP
City
Pardubice
ZIP/Postal Code
53009
Country
Czechia
Facility Name
DV Dent s.r.o.
City
Roudnice Nad Labem
ZIP/Postal Code
41301
Country
Czechia
Facility Name
Enta Dent s.r.o
City
Ústí Nad Labem
ZIP/Postal Code
400 01
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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