Use of Erbium Laser for Extraction of the Third Molars

NCT05540015 | Unknown DMC

• 1 other identifier: 6482963527
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

A comparative analysis of the effectiveness of the erbium laser with the wavelength of 2.94 µm and traditional instruments in the extraction of the impacted lower third molars will be performed. Clinical, radiological and biochemical findings will be assessed after extraction of the impacted lower third molars.

Conditions

Third Molar Extraction; Impacted Third Molar Tooth

Keywords

Impacted third molars; Erbium laser; Atraumatic extraction

Outcome Measures

Primary Outcomes (1)

• Assessment the level of bone regeneration according to Radiographic bone height (RBH)

  Assessment the level of bone regeneration according to Radiographic bone height (RBH) by cone beam computed tomography after extraction of the lower third molar. (Radiographic bone height (RBH)- is the distance between root apex of the distal root and uppermost intersecting point between distal root of the second molar and mesial wall of extraction socket, it will be measured on the cone beam computed tomography)

  Days 180 after extraction

Secondary Outcomes (14)

• Radiographic bone height (RBH)

  3;6 months

• Radiographic infrabony defect (RID)

  3;6 months

• Post-operative pain

  1;3;5;7;10 days

• Post-operative oedema

  1;3;5;7;10 days

• Soft tissue epithelization

  7;10;14

Study Arms (2)

Group with impacted third molar, extracted by cutting and rotary tools

ACTIVE COMPARATOR

The study group will include 28 patients with indications (impacted third molars that exerts pressure on the adjacent tooth and cause inflammation process in the surrounding tissue; absence of antagonist; pericorinitis; periodontitis; periodontal pockets) for the impacted third molar extraction. Patients will be comparable by gender and age, the patients age will be between 18 and 70 years. Patients should be with therapeutic and surgical oral hygiene and without co-morbidities.

Procedure: Third molar extraction by cutting and rotary tools

Group with impacted third molar, extracted by erbium laser 2.94 nm

ACTIVE COMPARATOR

The study group will include 28 patients with indications (impacted third molars that exerts pressure on the adjacent tooth and cause inflammation process in the surrounding tissue; absence of antagonist; pericorinitis; periodontitis; periodontal pockets) for the impacted third molar extraction.Patients will be comparable by gender and age, the patients age will be between 18 and 70 years. Patients should be with therapeutic and surgical oral hygiene and without co-morbidities.

Procedure: Third molar extraction by erbium laser with wavelength 2.94 nm

Interventions

Third molar extraction by cutting and rotary tools PROCEDURE

Extraction of the impacted lower third molar will be conducted using cutting and rotary tools under the local anesthesia (Ultracain D-S 1:100000 40 mg/ml, active substance- articaine+epinephrine, registration № П N015119/01 ). Scalpel will be used for the incision of the soft tissues, rotary instruments will be used for the bone tissue and tooth fragmentation. After the extraction the wound will be sutured by the suture material.

Group with impacted third molar, extracted by cutting and rotary tools

Third molar extraction by erbium laser with wavelength 2.94 nm PROCEDURE

Extraction of the impacted lower third molar will be conducted using erbium laser with wavelength 2.94 nm under the local anesthesia (Ultracain D-S 1:100000 40 mg/ml, active substance- articaine+epinephrine, registration № П N015119/01 ). The soft tissue and bone tissue will be dissected by erbium laser with wavelength 2.94 µm (Erbium laser Smart 2940D plus with the wavelength 2,94 µm, company- DEKA, Italy, registration № 2005/1245). After the extraction the wound will be sutured by the suture material (registration № ФСЗ 2010/06040; 07.08.2018)

Group with impacted third molar, extracted by erbium laser 2.94 nm

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing of written informed consent of the patient to participate in a study
• Age from 25 to 50 years old
• Indications for impacted third molar extraction
• Patients who are medically stable
• Therapeutic and surgical oral hygiene before surgery (absence of inflammatory diseases, caries, pulpitis, periodontitis in oral cavity)

You may not qualify if:

• Refusal of the patient from further participation in the study
• Non-compliance by the patient with postoperative recommendations
• Absence of a lower second molar

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Officials

• Diana Sologova

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Svetlana Tarasenko

CONTACT

+7-985-773-48-53; tarasenko_s_v@staff.sechenov.ru

Diana Sologova

CONTACT

+7-919-997-57-81; sologova_d_i@student.sechenov.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: December 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share