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

NCT ID: NCT03741894

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Primary wound closure

Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.

Group Type: PLACEBO_COMPARATOR

Wound closure using sutures

Intervention Type: OTHER

Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.

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.

Group Type: EXPERIMENTAL

Iodoform

Intervention Type: DRUG

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.

Wound closure using sutures

Intervention Type: OTHER

Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.

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.

Group Type: EXPERIMENTAL

Wound closure using sutures

Intervention Type: OTHER

Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.

Chlorhexidine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Wound closure using sutures

Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Balazs Soos

DMD, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Oral and Maxillofacial Surgery, University of Pécs

Pécs, , Hungary

Site Status: RECRUITING

Countries

Hungary

Facility Contacts

Jozsef Szalma, DMD, PhD

Role: primary

drszalma@freemail.hu

+3672535924

Other Identifiers

7065-PTE 2018.

Identifier Type: -

Identifier Source: org_study_id