Use of Erbium Laser for Extraction of the Third Molars

NCT ID: NCT05540015

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2025-08-31

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.

Detailed Description

A single-centre, interventional, non-randomized, prospective clinical trial in 2 parallel groups is planned. The lower third molars will be extracted in 60 patients. There will be 2 groups. The number of men and women in both groups will be the same, the patients age will be between 18 and 70 years. In the study group the lower third molars will be extracted using erbium laser with a wavelength of 2.94 µm (Erbium laser Smart 2940D plus with the wavelength 2,94 µm, company- DEKA, Italy, registration № 2005/1245), in the control group the lower third molars will be extracted using the conventional method (cutting and rotating instruments). Postoperative clinical symptoms such as collateral soft tissue swelling, postoperative pain, trismus in the extraction site and healing time (epithelization and bone regeneration) will be assessed. The epithelization will be assessed after 7, 10, 14 days. The bone regeneration will be assessed by cone beam computed tomography (KAVO, ORTHOPANTOMOGRAPH ОР 3D, type: РСХ-1; registration № РЗН 2020/10586) after 1, 3, 6 months. The radiation exposure will not exceed the permissible limits. Biochemical indicators in the saliva will be assessed before extraction, after extraction, 3 days and 7 days after the extraction. The Shapiro-Wilk test will be applied to check the normality of variable distribu- tion. Qualitative variables will be analyzed by Pearson's chi-squared test. Quantitative variables (normal distribution of variable) will be analyzed by Students t-test, non-normal distribution of variables will be analyzed by Mann-Whitney U test.

Conditions

Third Molar Extraction; Impacted Third Molar Tooth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

Third molar extraction by cutting and rotary tools

Intervention Type: 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 erbium laser 2.94 nm

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.

Group Type: ACTIVE_COMPARATOR

Third molar extraction by erbium laser with wavelength 2.94 nm

Intervention Type: 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)

Interventions

Third molar extraction by cutting and rotary tools

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.

Intervention Type: PROCEDURE

Third molar extraction by erbium laser with wavelength 2.94 nm

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)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Signing of written informed consent of the patient to participate in a study

2. Age from 25 to 50 years old

3. Indications for impacted third molar extraction

4. Patients who are medically stable

5. Therapeutic and surgical oral hygiene before surgery (absence of inflammatory diseases, caries, pulpitis, periodontitis in oral cavity)

Exclusion Criteria

1. Refusal of the patient from further participation in the study

2. Pregnancy diagnosed after the inclusion into the trial

3. Non-compliance by the patient with postoperative recommendations

4. Absence of a lower second molar

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana Sologova

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Svetlana Tarasenko

Role: CONTACT

tarasenko_s_v@staff.sechenov.ru

+7-985-773-48-53

Diana Sologova

Role: CONTACT

sologova_d_i@student.sechenov.ru

+7-919-997-57-81

Other Identifiers

6482963527

Identifier Type: -

Identifier Source: org_study_id