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

Impacted Third Molar Tooth Clinical Trial

— AITS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03741894
• Other study ID #: 7065-PTE 2018.
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2018
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

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.

Locations

Country	Name	City	State
Hungary	Department of Oral and Maxillofacial Surgery, University of Pécs	Pécs

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in minor postoperative complications (trismus)	Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).	day of surgery, 3rd, 7th postoperative days
Primary	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
Primary	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
Primary	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
Primary	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