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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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)
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)
Time frame: Days 180 after extraction
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 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)
Time frame: 3;6 months
Radiographic infrabony defect (RID)
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)
Time frame: 3;6 months
Post-operative pain
Post-operative pain will be assessed by 10-point visual analogue scale (VAS) in the area of the extracted tooth
Time frame: 1;3;5;7;10 days
Post-operative oedema
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1;3;5;7;10 days
Soft tissue epithelization
Assessment the soft tissue epithelization using a photoprotocol (the day on which full tissue regeneration has taken place will be taken into account)
Time frame: 7;10;14
Trismus
Assessment the distance between upper and lower incisors in mm
Time frame: 1;3;5;7;10 days
sRANKL (soluble receptor activator of nuclear factor-κB ligand)
Assessment the level of sRANKL in saliva by enzyme-linked immunosorbent assay, ELISA
Time frame: before surgery, after surgery, 3;7 days
OPG (osteoprotegerin)
Assessment the level of OPG in saliva by enzyme-linked immunosorbent assay, ELISA
Time frame: before surgery, after surgery, 3;7 days
Fibroblast growth factor-b (FGF-b)
Assessment the level of FGF-b in saliva
Time frame: before surgery, after surgery, 3;7 days
C-reactive protein (CRP)
Assessment the level of CRP in saliva by enzyme-linked immunosorbent assay
Time frame: before surgery, after surgery, 3;7 days
IgA
Assessment the level of IgA in saliva by enzyme-linked immunosorbent assay
Time frame: before surgery, after surgery, 3;7 days
IgG
Assessment the level of IgG in saliva by enzyme-linked immunosorbent assay
Time frame: before surgery, after surgery, 3;7 days
IgM
Assessment the level of IgM in saliva by enzyme-linked immunosorbent assay
Time frame: before surgery, after surgery, 3;7 days
Vascular endothelial growth factor (VEGF)
Assessment the level of VEGF in saliva by enzyme-linked immunosorbent assay
Time frame: before surgery, after surgery, 3;7 days