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

Phase 4

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

• Registration Number: NCT03741894
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-10-30
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-12
• Last Update Submitted: 2018-11-12
• Study First Posted: 2018-11-15
• Last Update Posted: 2018-11-15
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary wound closure	Wound closure using sutures	Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
Iodoform and wound closure	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 (Surgilon 3-0 non-absorbable) placements for a week.
Chlorhexidine and wound closure	Wound closure using sutures	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.
Iodoform and wound closure	Wound closure using sutures	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.
Chlorhexidine and wound closure	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

Name	Time	Method
Change in minor postoperative complications (trismus)	day of surgery, 3rd, 7th postoperative days	Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).
Change in minor postoperative complications (oedema)	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).
Change in necessity of postoperatively taken analgesics	1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days	Registering number of daily repeats of taken analgesics.
Change in minor postoperative complications (pain)	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

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Surgery, University of Pécs; 🇭🇺 Pécs, Hungary