Clinical trial NCT05540015: Use of Erbium Laser for Extraction of the Third Molars
Official title: Use of Erbium Laser With the Wavelength 2.94 nm for Extraction of the Impacted Lower Third Molars
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Third Molar Extraction
Impacted Third Molar Tooth
Keywords: Impacted third molars
Erbium laser
Atraumatic extraction
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment the level of bone regeneration according to Radiographic bone height (RBH)
timeFrame: Days 180 after extraction
Secondary outcomes:
measure: Radiographic bone height (RBH)
timeFrame: 3;6 months
measure: Radiographic infrabony defect (RID)
timeFrame: 3;6 months
measure: Post-operative pain
timeFrame: 1;3;5;7;10 days
measure: Post-operative oedema
timeFrame: 1;3;5;7;10 days
measure: Soft tissue epithelization
timeFrame: 7;10;14
measure: Trismus
timeFrame: 1;3;5;7;10 days
measure: sRANKL (soluble receptor activator of nuclear factor-κB ligand)
timeFrame: before surgery, after surgery, 3;7 days
measure: OPG (osteoprotegerin)
timeFrame: before surgery, after surgery, 3;7 days
measure: Fibroblast growth factor-b (FGF-b)
timeFrame: before surgery, after surgery, 3;7 days
measure: C-reactive protein (CRP)
timeFrame: before surgery, after surgery, 3;7 days
measure: IgA
timeFrame: before surgery, after surgery, 3;7 days
measure: IgG
timeFrame: before surgery, after surgery, 3;7 days
measure: IgM
timeFrame: before surgery, after surgery, 3;7 days
measure: Vascular endothelial growth factor (VEGF)
timeFrame: before surgery, after surgery, 3;7 days
Other outcomes:
Locations:
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Diana Sologova
role: PRINCIPAL_INVESTIGATOR
References: