Skip to main content
OpenTrials
Completed

NCT Number: NCT05680285

Evaluation of Low Level Laser Therapy in Primary Tooth Pulpotomy Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulpotomy

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Usak University

Uşak, 64200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diode lazer

Device

diode laser was applied during the pulpotomy procedure

low level diode laser

Device

Low-dose diode laser was applied during the pulpotomy procedure

Primary outcomes

  1. radiographic success of treatments at the end of 12 months

    Time frame: 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

  2. clinical success of treatments at the end of 12 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2023
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.