Tooth Extraction Clinical Trial
Official title:
Effect of the Low Power Laser in the Treatment of Pain After the Third Molar Lower Extraction. A Randomised Single-blind Clinical Trial Split-mouth
Verified date | November 2023 |
Source | University of Santiago de Compostela |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: Previously published studies report a prevalence ranging from 35.9% to 58.7% of the general population with at least one impacted wisdom tooth. Surgical extraction of wisdom teeth is the procedure most often associated with postoperative complications, such as pain, swelling, trismus, and oral discomfort during the first postoperative days. These complications arise from an inflammatory response, which is a direct and immediate consequence of the surgical intervention and can limit the patients' daily functions in the recovery phase and compromise their quality of life. Several methods have been used to control postoperative morbidity related to wisdom tooth extraction, including administration of proteolytic enzymes, tube drains, cryotherapy, anti-inflammatory and analgesic drugs and low level laser therapy. Objectives: To test whether the use of low power laser can improve post-operative pain, swelling and healing of the surgical wound. Material and methods: A double-centre, randomised, split-mouth, double-centre clinical study will be carried out in 38 patients per centre, totalling 76 patients and 152 wisdom teeth, who will undergo surgery for the extraction of the lower third molars. The necessary data for the study will be taken on the days of the consultation for surgery planning, on the day of surgery, by the patient on each post-operative day and on the 7th post-operative day (at the time of suture removal ).
Status | Completed |
Enrollment | 80 |
Est. completion date | November 14, 2023 |
Est. primary completion date | July 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who require extraction of the two lower wisdom teeth due to previous infection or pain, orthodontics or crowding, caries and who have a similar degree of difficulty according to the Pell and Gregory/Winter classifications. - Patients must have the capacity to understand and decide at the time of voluntarily signing the informed consent before any intervention related to the study is performed. - Patients who, after being informed about the aims and procedures of the research, agree and sign the informed consent form. Patients must be willing and able to adhere to the study in order to complete the necessary visits. Exclusion Criteria: - Patients with uncontrolled systemic disease (ASA = III). - Patients with severe periodontal disease or acute pericoronitis. - Smokers of more than 5 cigarettes per day. - Pregnant and lactating women, as the effect of laser therapy in this population has not been studied, its use is contraindicated. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de Santiago de Compostela | Santiago De Compostela | A Coruña |
Lead Sponsor | Collaborator |
---|---|
University of Santiago de Compostela |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate edema after surgery | To evaluate the effect of diode laser radiation of 808 nm (infrared) applied intra and extra-orally on the post-operative edema (by measuring in centimetres obtained by a ruler - external contour of the face from the tragus to the labial comisure, from the gonion to the external ocular corner, the greater the measurement obtained, when compared with the initial measurement, the greater the post-operative edema). | 7 days | |
Primary | Evaluate improved healing after surgery | To evaluate the effect of diode laser radiation of 808 nm (infrared) applied intra-orally in the healing (by the Landry et al. scale from 0 to 5, where 0 means poor healing and 5 means excellent healing.). | 7 days | |
Secondary | Pain reported | The degree of pain reported by patients using a visual analogue scale (VAS). Scale from 0 to 10, where zero means no pain and ten means severe pain | 7 days | |
Secondary | Amount of pain medication | To assess whether there has been a change in the amount of pills consumed as rescue medication for pain management. Through the number of pills used by the patient after each surgery. | 7 days | |
Secondary | Trismus | With a ruler the distance of the maximum opening between the upper right and lower right central incisors before surgery will be measured (the measurement in centimetres). The smaller the measurement of mouth opening obtained, compared to the initial measurement, the greater the post-operative trismus) | 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04166890 -
Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia
|
Phase 4 | |
Active, not recruiting |
NCT02952209 -
The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla
|
N/A | |
Completed |
NCT02155764 -
Ridge Preservation With New Class of Osteoplastic Materials
|
Phase 2 | |
Completed |
NCT01588444 -
Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft
|
N/A | |
Completed |
NCT00387140 -
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)
|
Phase 2 | |
Recruiting |
NCT06245161 -
Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients
|
N/A | |
Recruiting |
NCT05615272 -
Treatment of Alveolar Osteitis: Traditional or Regenerative?
|
N/A | |
Completed |
NCT05101954 -
Platelet Rich Fibrin and Concentrated Growth Factors on Osseointegration of Immediate Implants
|
N/A | |
Completed |
NCT03985033 -
The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing
|
N/A | |
Completed |
NCT04082598 -
Antibiotic Therapy in Erupted Tooth Extractions
|
Phase 4 | |
Completed |
NCT01924390 -
Histological Comparison of Ridge Preservation Using Mineralized FDBA Alone Versus a Combined Mineralized-Demineralized Freeze Dried Bone Allograft
|
N/A | |
Completed |
NCT04930497 -
Vestibular Socket Therapy With and Without Bone Grafting
|
N/A | |
Completed |
NCT03191448 -
Ridge Preservation Using FDBA and a Collagen Wound Dressing in Molar Sites
|
N/A | |
Completed |
NCT03211312 -
Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases
|
||
Withdrawn |
NCT06038695 -
Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB
|
N/A | |
Completed |
NCT05845437 -
On Adequacy of Referrals to Oral and Maxillofacial Surgery
|
||
Recruiting |
NCT05220462 -
Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for Dental Extractions.
|
Phase 3 | |
Active, not recruiting |
NCT03943680 -
Plasma Rich in Growth Factors in Post-extraction Sockets
|
N/A | |
Recruiting |
NCT05106855 -
Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation.
|
N/A | |
Completed |
NCT03487718 -
A 14 Weeks Longitudinal Study to Investigate the Effect of Leukocyte- Platelet Rich Fibrin Plug on the Quality of the Newly Formed Bone in Ridge Preservation Procedure Following a Tooth Extraction. It is a Clinical, Radiographic and Histomorphometric Study.
|
N/A |