Use of Erbium Laser for Extraction of the Third Molars

Not Applicable

Not yet recruiting

• Conditions: Third Molar Extraction; Impacted Third Molar Tooth

• Registration Number: NCT05540015
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Study First Posted: 2022-09-14
• Last Update Posted: 2022-09-14
• Study Start: 2022-12
• Primary Completion: 2024-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment the level of bone regeneration according to Radiographic bone height (RBH)	Days 180 after extraction	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)

Secondary Outcome Measures

Name	Time	Method
Radiographic bone height (RBH)	3;6 months	Assessment the level of bone regeneration according to Radiographic bone height (RBH) by cone beam computed tomography after extraction of the lower third molar with erbium laser. (Radiographic bone height (RBH)- is the distance between root apex of the distal root of the second molar 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)
Radiographic infrabony defect (RID)	3;6 months	Assessment the level of bone regeneration according to Radiographic infrabony defect (RID) by cone beam computed tomography after extraction of the lower third molar with erbium laser. (Radiographic infrabony defect (RID) is the distance between cemento-enamel junction of the second molar 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)
Post-operative pain	1;3;5;7;10 days	Post-operative pain will be assessed by 10-point visual analogue scale (VAS) in the area of the extracted tooth
Post-operative oedema	1;3;5;7;10 days	Assessment the soft tissue epithelization using six-point Visual Analogue Scale (VAS) of swelling, where 0 indicates "no swelling", and 5 indicates "extreme severe swelling
Soft tissue epithelization	7;10;14	Assessment the soft tissue epithelization using a photoprotocol (the day on which full tissue regeneration has taken place will be taken into account)
Trismus	1;3;5;7;10 days	Assessment the distance between upper and lower incisors in mm
sRANKL (soluble receptor activator of nuclear factor-κB ligand)	before surgery, after surgery, 3;7 days	Assessment the level of sRANKL in saliva by enzyme-linked immunosorbent assay, ELISA
OPG (osteoprotegerin)	before surgery, after surgery, 3;7 days	Assessment the level of OPG in saliva by enzyme-linked immunosorbent assay, ELISA
Fibroblast growth factor-b (FGF-b)	before surgery, after surgery, 3;7 days	Assessment the level of FGF-b in saliva
C-reactive protein (CRP)	before surgery, after surgery, 3;7 days	Assessment the level of CRP in saliva by enzyme-linked immunosorbent assay
IgA	before surgery, after surgery, 3;7 days	Assessment the level of IgA in saliva by enzyme-linked immunosorbent assay
IgG	before surgery, after surgery, 3;7 days	Assessment the level of IgG in saliva by enzyme-linked immunosorbent assay
IgM	before surgery, after surgery, 3;7 days	Assessment the level of IgM in saliva by enzyme-linked immunosorbent assay
Vascular endothelial growth factor (VEGF)	before surgery, after surgery, 3;7 days	Assessment the level of VEGF in saliva by enzyme-linked immunosorbent assay