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Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery (AITS)

Primary Purpose

Alveolitis of Jaw, Alveoli, Teeth; Inflammation, Dry Socket

Status
Unknown status
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Iodoform
Wound closure using sutures
Chlorhexidine
Sponsored by
University of Pecs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alveolitis of Jaw focused on measuring alveolitis, iodoform, chlorhexidine, minor complications

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pell-Gregory II/B impaction
  • mesioangular impactions
  • tooth sectioning is not necessary for removal
  • without local infection of third molar

Exclusion Criteria:

  • no general diseases or following treatments (DM, steroids, bleeding risk, chemotherapy, radiotherapy, bisphosphonates, immunosuppressive conditions)

Sites / Locations

  • Department of Oral and Maxillofacial Surgery, University of PécsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Primary wound closure

Iodoform and wound closure

Chlorhexidine and wound closure

Arm Description

Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.

Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture (Surgilon 3-0 non-absorbable) placements for a week.

Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.

Outcomes

Primary Outcome Measures

Change in minor postoperative complications (trismus)
Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).
Change in minor postoperative complications (oedema)
measuring postoperative oedema (flexible ruler- lateral canthus-mandibular angle distance in millimeters and tragus-labial commissure distance in millimeters).
Change in minor postoperative complications (pain)
Measuring level of pain in Visual Analog Scale (minimum score is 0 which represents no pain, maximum score is 10 which shows the worst pain) postoperatively
Change in necessity of postoperatively taken analgesics
Registering dose of active agent of taken analgesics in milligrams .
Change in necessity of postoperatively taken analgesics
Registering number of daily repeats of taken analgesics.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2018
Last Updated
November 12, 2018
Sponsor
University of Pecs
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1. Study Identification

Unique Protocol Identification Number
NCT03741894
Brief Title
Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
Acronym
AITS
Official Title
Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pecs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the everyday clinical practice the incidence of minor complications is approximately 15-20% of the total number of third molar removals. Alveolitis (dry socket syndrome) may arise in 30-40% of the surgical tooth removals. Several preventive approaches are known, such as the use of iodoform gauze, zink-oxide eugenol paste, platelet rich fibrin (PRF), different medicine containing pastes, like antibiotics containing, non-steroid pain killer containing, steroid containing, or the application of chlorhexidine gel and solutions. In the case of a manifest alveolitis these methods can be used as well. The aims of this research are: i) to identify the important pathogens which play role in the development of alveolitis (microbiological methods), ii) to analyze the in vitro effectivity of the different antiseptic materials in case of infections (inhibitory zones) iii) to compare the effectivity of different alveolitis preventive methods in a prospective clinical study, iv) to compare the different treatment options in alveolitis in a prospective clinical study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolitis of Jaw, Alveoli, Teeth; Inflammation, Dry Socket, Impacted Third Molar Tooth
Keywords
alveolitis, iodoform, chlorhexidine, minor complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary wound closure
Arm Type
Placebo Comparator
Arm Description
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
Arm Title
Iodoform and wound closure
Arm Type
Experimental
Arm Description
Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture (Surgilon 3-0 non-absorbable) placements for a week.
Arm Title
Chlorhexidine and wound closure
Arm Type
Experimental
Arm Description
Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.
Intervention Type
Drug
Intervention Name(s)
Iodoform
Intervention Description
Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture placements for a week.
Intervention Type
Other
Intervention Name(s)
Wound closure using sutures
Intervention Description
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Description
Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.
Primary Outcome Measure Information:
Title
Change in minor postoperative complications (trismus)
Description
Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).
Time Frame
day of surgery, 3rd, 7th postoperative days
Title
Change in minor postoperative complications (oedema)
Description
measuring postoperative oedema (flexible ruler- lateral canthus-mandibular angle distance in millimeters and tragus-labial commissure distance in millimeters).
Time Frame
day of surgery, 3rd, 7th postoperative days
Title
Change in minor postoperative complications (pain)
Description
Measuring level of pain in Visual Analog Scale (minimum score is 0 which represents no pain, maximum score is 10 which shows the worst pain) postoperatively
Time Frame
1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Title
Change in necessity of postoperatively taken analgesics
Description
Registering dose of active agent of taken analgesics in milligrams .
Time Frame
1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Title
Change in necessity of postoperatively taken analgesics
Description
Registering number of daily repeats of taken analgesics.
Time Frame
1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pell-Gregory II/B impaction mesioangular impactions tooth sectioning is not necessary for removal without local infection of third molar Exclusion Criteria: no general diseases or following treatments (DM, steroids, bleeding risk, chemotherapy, radiotherapy, bisphosphonates, immunosuppressive conditions)
Facility Information:
Facility Name
Department of Oral and Maxillofacial Surgery, University of Pécs
City
Pécs
ZIP/Postal Code
7621
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jozsef Szalma, DMD, PhD
Phone
+3672535924
Email
drszalma@freemail.hu
First Name & Middle Initial & Last Name & Degree
Jozsef Szalma, DMD, PhD
First Name & Middle Initial & Last Name & Degree
Laszlo Vajta, DMD
First Name & Middle Initial & Last Name & Degree
Balázs Soós, DMD
First Name & Middle Initial & Last Name & Degree
Kata Janovics, DMD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery

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