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

NCT03741894 | Unknown Phase 4

• 1 other identifier: 7065-PTE 2018.
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

alveolitis; iodoform; chlorhexidine; minor complications

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Primary wound closure

PLACEBO COMPARATOR

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

Other: Wound closure using sutures

Iodoform and wound closure

EXPERIMENTAL

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; Other: Wound closure using sutures

Chlorhexidine and wound closure

EXPERIMENTAL

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; Drug: Chlorhexidine

Interventions

Iodoform 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.

Iodoform and wound closure

Wound closure using sutures OTHER

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

Chlorhexidine and wound closure; Iodoform and wound closure; Primary wound closure

Chlorhexidine 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.

Chlorhexidine and wound closure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pell-Gregory II/B impaction
• mesioangular impactions
• tooth sectioning is not necessary for removal
• without local infection of third molar

You may not qualify if:

• no general diseases or following treatments (DM, steroids, bleeding risk, chemotherapy, radiotherapy, bisphosphonates, immunosuppressive conditions)

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery, University of Pécs

Pécs, 7621, Hungary

RECRUITING

MeSH Terms

Conditions

Dry Socket; Inflammation

Interventions

iodoform; Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD, Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 15, 2018
• Study Start: September 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2021
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

HU (1)