Evaluation of Low Level Laser Therapy in Primary Tooth Pulpotomy Treatment

Pulpotomy Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Low Level Laser Therapy in Primary Tooth Pulpotomy Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05680285
• Other study ID #: UsakU10
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: December 2022
• Source: Usak University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In our study, it was aimed to compare the long-term effectiveness of diode laser and low level laser therapy and primary tooth amputation treatments using calcium hydroxide (LLLT+CH) in primary second molars with deep dentinal caries. Ninety patients ( 42 Gırl, 48 Boy) aged 6-9 years with deep dentin caries in the mandibular second molar were included in the study. The patients were randomly selected according to the treatment to be applied and divided into two groups as the diode laser group (N=45) and the LLLT+CH group (N=45). The patients were called for control appointments at the 1st, 3rd, 6th and 12th months after the treatment, and both clinical and radiographic follow-ups were performed. Chi-square and Fisher's Exact tests were used to compare categorical variables according to groups in statistical analysis, and p<0.05 was considered significant. When the study results at the end of 12 months were evaluated, the diode laser group had a clinical success rate of 95.6%, and a success rate of 93.3% radiologically; The LLLT+CH group had a success rate of 97.7% clinically and 90.9% radiologically. There was no statistically significant difference between the success rates of the groups (p>0.05). According to the clinical and radiographic results of our study, it was determined that diode laser and LLLT+CH amputations showed similar success rates in primary second molars with deep dentin caries. It has been seen that both methods can be used safely in primary tooth amputations. It is thought that clinical and histological studies and studies examining the effectiveness of dental laser applications in primary tooth amputation treatment are needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria:

Clinical Criteria

• No systemic disease

• Not allergic to the materials used

• Children with scores of 1 and 2 according to the Frankel behavioral scale

• Those who have erupted permanent first molars

• The one in occlusion with the opposing tooth

• Not having bad oral habits

• No structural anomaly in the teeth

• No spontaneous or nocturnal pain

• No sensitivity to palpation or percussion

• Abscess and fistula formation free

• No pathological mobility

• During treatment, pulp bleeding is controlled within 5 minutes.

• With a crown that can be made of stainless steel crown (PÇK)

Radiographic Criteria

• Having a deep dentin caries lesion very close to the pulp

• No resorption in the bifurcation and periapical area

• Periodontal space is healthy and there is no periapical region pathology

• Absence of internal and external root resorption in roots

• No calcified masses in the pulp

• Teeth that did not exceed one-third of the physiological root resorption were included in the study.

Exclusion Criteria

-Children with a score of 1 and 4 on the Frankel Scale were excluded.

Related Conditions & MeSH terms

• Pulpotomy

Intervention

Device:
• diode lazer
diode laser was applied during the pulpotomy procedure
• low level diode laser
Low-dose diode laser was applied during the pulpotomy procedure

Locations

Country	Name	City	State
Turkey	Usak University	Usak

Sponsors (1)

Lead Sponsor	Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiographic success of treatments at the end of 12 months	teeth without any signs of pathological internal and external root resorption, enlargement of the periodontal space, and radiolucency in the periapical and furcation region	12 months
Primary	clinical success of treatments at the end of 12 months	teeth without any of the signs of spontaneous pain, tenderness on palpation and percussion, pathological mobility, sinus tract or gingival abscess form, lymphodanepathy in the relevant region	12 months