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

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ClinicalTrials.gov Identifier: NCT03741894
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Balazs Soos, University of Pecs

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.

Condition or disease Intervention/treatment Phase
Alveolitis of Jaw Alveoli, Teeth; Inflammation Dry Socket Impacted Third Molar Tooth Drug: Iodoform Other: Wound closure using sutures Drug: Chlorhexidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021


Arm Intervention/treatment
Placebo Comparator: Primary wound closure
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
Other: Wound closure using sutures
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.

Experimental: Iodoform and wound closure
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.
Drug: Iodoform
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.

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

Experimental: Chlorhexidine and wound closure
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.
Other: Wound closure using sutures
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.

Drug: Chlorhexidine
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 Measures :
  1. Change in minor postoperative complications (trismus) [ Time Frame: day of surgery, 3rd, 7th postoperative days ]
    Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).

  2. Change in minor postoperative complications (oedema) [ Time Frame: day of surgery, 3rd, 7th postoperative days ]
    measuring postoperative oedema (flexible ruler- lateral canthus-mandibular angle distance in millimeters and tragus-labial commissure distance in millimeters).

  3. Change in minor postoperative complications (pain) [ Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days ]
    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

  4. Change in necessity of postoperatively taken analgesics [ Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days ]
    Registering dose of active agent of taken analgesics in milligrams .

  5. Change in necessity of postoperatively taken analgesics [ Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days ]
    Registering number of daily repeats of taken analgesics.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

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): NCT03741894


Locations
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Hungary
Department of Oral and Maxillofacial Surgery, University of Pécs Recruiting
Pécs, Hungary, 7621
Contact: Jozsef Szalma, DMD, PhD    +3672535924    drszalma@freemail.hu   
Principal Investigator: Jozsef Szalma, DMD, PhD         
Sub-Investigator: Laszlo Vajta, DMD         
Principal Investigator: Balázs Soós, DMD         
Sub-Investigator: Kata Janovics, DMD         
Sponsors and Collaborators
University of Pecs

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Responsible Party: Balazs Soos, DMD, Assistant Professor, University of Pecs
ClinicalTrials.gov Identifier: NCT03741894     History of Changes
Other Study ID Numbers: 7065-PTE 2018.
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Balazs Soos, University of Pecs:
alveolitis
iodoform
chlorhexidine
minor complications

Additional relevant MeSH terms:
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Inflammation
Tooth, Impacted
Dry Socket
Pathologic Processes
Tooth Diseases
Stomatognathic Diseases
Mouth Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents