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

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.

Study Overview

• Status: Unknown
• Conditions: Impacted Third Molar Tooth; Dry Socket; Alveolitis of Jaw; Alveoli, Teeth; Inflammation
• Intervention / Treatment: Other: Wound closure using sutures; Drug: Iodoform; Drug: Chlorhexidine

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Pécs, Hungary, 7621
    • Recruiting
    • Department of Oral and Maxillofacial Surgery, University of Pécs
    • Contact: Jozsef Szalma, DMD, PhD; Phone Number: +3672535924; Email: drszalma@freemail.hu
    • Principal Investigator: Jozsef Szalma, DMD, PhD
    • Sub-Investigator: Laszlo Vajta, DMD
    • Principal Investigator: Balázs Soós, DMD
    • Sub-Investigator: Kata Janovics, DMD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in minor postoperative complications (trismus)	Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).	day of surgery, 3rd, 7th postoperative days
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).	day of surgery, 3rd, 7th postoperative days
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	1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Change in necessity of postoperatively taken analgesics	Registering dose of active agent of taken analgesics in milligrams .	1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Change in necessity of postoperatively taken analgesics	Registering number of daily repeats of taken analgesics.	1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days

Collaborators and Investigators

• Sponsor: University of Pecs

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: chlorhexidine; alveolitis; iodoform; minor complications
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Inflammation; Tooth, Impacted; Dry Socket; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 7065-PTE 2018.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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