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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alveolitis of Jaw, Alveoli, Teeth; Inflammation, Dry Socket, Impacted Third Molar Tooth

Intervention / Treatment
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* Drug: Iodoform
* Other: Wound closure using sutures
* Drug: Chlorhexidine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Primary wound closure<br>Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only. | Other: Wound closure using sutures<br>* Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.<br>|
| Experimental: Iodoform and wound closure<br>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<br>* 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.<br>Other: Wound closure using sutures<br>* Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.<br>|
| Experimental: Chlorhexidine and wound closure<br>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<br>* Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.<br>Drug: Chlorhexidine<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alveolitis, iodoform, chlorhexidine, minor complications