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

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ClinicalTrials.gov Identifier: NCT04091399
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Contipro Pharma a.s.

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.


Condition or disease Intervention/treatment Phase
Alveolar Osteitis Drug: Stamatological tamponade Contipro Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Intervention Model Description:
  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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-centre, Open-label, First-in-man Study of Adult Patients Suffered From Alveolar Osteitis Treated Using Stomatological Tamponade Contipro
Actual Study Start Date : September 11, 2015
Actual Primary Completion Date : February 12, 2016
Actual Study Completion Date : February 12, 2016

Arm Intervention/treatment
Experimental: Patient cohort
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
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 Measures :
  1. The number of patients with treated related adverse effects objectively evaluated by examiners [ Time Frame: 7 days/per patient ]
    The prevalence of potential treatment-relatived adverse effect evaluated by dentists in follow-up examinations


Secondary Outcome Measures :
  1. Pain change assessed by the VAS scale according to subjective evaluation by patients [ Time Frame: 7 days/per patient ]
    Pain change was assessed by the VAS scale. Pain relief associated with treatment was determinated as drop on the VAS scale below 20 mm


Other Outcome Measures:
  1. Extraction wound healing assessed by objectively evaluation of examiners [ Time Frame: 7 days/per patient ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091399


Locations
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Czechia
IchtysDent s.r.o
Brno, Czechia, 60200
University Hospital Brno, Clinic of Oral, Maxillary and Facial Surgery
Brno, Czechia, 62500
Prouzovi s.r.o.
Dvůr Králové Nad Labem, Czechia, 54401
University Hospital Hradec Králové, Department of Dentistry
Hradec Králové, Czechia, 50005
Dentine s.r.o.
Jičín, Czechia, 50601
FSmile s.r.o.
Opočno, Czechia, 51773
Dentpra
Pardubice, Czechia, 53002
Mojmír Strnad
Pardubice, Czechia, 53002
MEDIKAP
Pardubice, Czechia, 53009
DV Dent s.r.o.
Roudnice Nad Labem, Czechia, 41301
Enta Dent s.r.o
Ústí Nad Labem, Czechia, 400 01
Sponsors and Collaborators
Contipro Pharma a.s.
Investigators
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Principal Investigator: Jakub Suchánek, MUDr. University Hospital Hradec Králové

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Responsible Party: Contipro Pharma a.s.
ClinicalTrials.gov Identifier: NCT04091399     History of Changes
Other Study ID Numbers: PT-ST-1_12-14
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Contipro Pharma a.s.:
first-man-study
alveolitis sicca dolorosa
alveolar osteitis
alveolalgia
sodium hyaluronate
octenidine hydrochlorid
clinical study
Additional relevant MeSH terms:
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Osteitis
Dry Socket
Bone Diseases
Musculoskeletal Diseases
Mouth Diseases
Stomatognathic Diseases
Octenidine
Anti-Infective Agents
Anti-Infective Agents, Local