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

U

University of Pecs

Status and phase

Unknown
Phase 4

Conditions

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

Treatments

Drug: Chlorhexidine
Other: Wound closure using sutures
Drug: Iodoform

Study type

Interventional

Funder types

Other

Identifiers

NCT03741894
7065-PTE 2018.

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 3 patient groups, including a placebo group

Primary wound closure
Placebo Comparator group
Description:
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
Treatment:
Other: Wound closure using sutures
Iodoform and wound closure
Experimental group
Description:
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.
Treatment:
Other: Wound closure using sutures
Drug: Iodoform
Chlorhexidine and wound closure
Experimental group
Description:
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.
Treatment:
Other: Wound closure using sutures
Drug: Chlorhexidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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