Use of Erbium Laser for Extraction of the Third Molars

Impacted Third Molar Tooth Clinical Trial

Official title:

Use of Erbium Laser With the Wavelength 2.94 nm for Extraction of the Impacted Lower Third Molars

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05540015
• Other study ID #: 6482963527
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: August 2025

Study information

• Verified date: September 2022
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Svetlana Tarasenko
• Phone: +7-985-773-48-53
• Email: tarasenko_s_v[@]staff.sechenov.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Third Molar Extraction
• Tooth, Impacted

Intervention

Procedure:
• 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 ? ? 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.
• 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 ? ? 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 ? ??? 2010/06040; 07.08.2018)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	3;6 months
Secondary	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)	3;6 months
Secondary	Post-operative pain	Post-operative pain will be assessed by 10-point visual analogue scale (VAS) in the area of the extracted tooth	1;3;5;7;10 days
Secondary	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	1;3;5;7;10 days
Secondary	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)	7;10;14
Secondary	Trismus	Assessment the distance between upper and lower incisors in mm	1;3;5;7;10 days
Secondary	sRANKL (soluble receptor activator of nuclear factor-?B ligand)	Assessment the level of sRANKL in saliva by enzyme-linked immunosorbent assay, ELISA	before surgery, after surgery, 3;7 days
Secondary	OPG (osteoprotegerin)	Assessment the level of OPG in saliva by enzyme-linked immunosorbent assay, ELISA	before surgery, after surgery, 3;7 days
Secondary	Fibroblast growth factor-b (FGF-b)	Assessment the level of FGF-b in saliva	before surgery, after surgery, 3;7 days
Secondary	C-reactive protein (CRP)	Assessment the level of CRP in saliva by enzyme-linked immunosorbent assay	before surgery, after surgery, 3;7 days
Secondary	IgA	Assessment the level of IgA in saliva by enzyme-linked immunosorbent assay	before surgery, after surgery, 3;7 days
Secondary	IgG	Assessment the level of IgG in saliva by enzyme-linked immunosorbent assay	before surgery, after surgery, 3;7 days
Secondary	IgM	Assessment the level of IgM in saliva by enzyme-linked immunosorbent assay	before surgery, after surgery, 3;7 days
Secondary	Vascular endothelial growth factor (VEGF)	Assessment the level of VEGF in saliva by enzyme-linked immunosorbent assay	before surgery, after surgery, 3;7 days