AITS: Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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 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
- Change in necessity of postoperatively taken analgesics [1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days]
Registering dose of active agent of taken analgesics in milligrams .
- 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.
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Oral and Maxillofacial Surgery, University of Pécs | Pécs | Hungary | 7621 |
Sponsors and Collaborators
- University of Pecs
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 7065-PTE 2018.