Pulpotomy Clinical Trial
Official title:
Clinical and Radiographic Evaluation of Low-level Laser Therapy in Human Primary Molar Pulpotomies: A Randomized Controlled Clinical Trial
Verified date | December 2018 |
Source | King Abdulaziz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aimed to assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth. One hundred and six primary molars from 36 children aging five to eight years were included and randomly assigned into two equal groups; LLLT group and FC group. Teeth were evaluated clinically and radiographically at 3, 6 and 12 months.
Status | Completed |
Enrollment | 36 |
Est. completion date | February 1, 2018 |
Est. primary completion date | February 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 8 Years |
Eligibility |
Inclusion Criteria: Children inclusion criteria: - Children aged 5-8 years with at least two bilateral deep carious primary molars indicated for pulpotomy. - Children who are physically and mentally healthy without any known medical history of systemic conditions contraindicating pulp therapy. - Children who had "positive" or "definitely positive" behavioral ratings according to the Frankl behavior classification scale (Frankl, 1962). - Children whose parents signed an informed consent for the child's participation in the study. Teeth inclusion criteria: Teeth were selected according to clinical and radiographic criteria. Clinically, the study included: - Teeth with restorable crowns - Teeth with pathologic carious exposure of vital pulps - Teeth with no tenderness to percussion, physiologic or pathologic mobility or any clinical evidence of pulp inflammation or degeneration such as history of swelling, pain or presence of sinus tract. Radiographically, the recruited teeth should have: - Normal radiographic appearance with healthy supporting tissues - No pulp calcification - No internal or external root resorption - No periapical or inter-radicular radiolucency - At least two thirds of the root remaining (not more than one third of the root is physiologically resorbed) Exclusion Criteria: - Any child complained of clinical signs such as pain, swelling, abnormal mobility, vertical or lateral tenderness to percussion was excluded from the study. - Radiographically, any child with signs of internal or external root resorption or periapical or inter-radicular pathology was omitted from the study. |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Abdulaziz University, Dental University Hospital | Jeddah |
Lead Sponsor | Collaborator |
---|---|
King Abdulaziz University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical success rate | The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility | 3 months | |
Primary | Clinical success rate | The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility | 6 months | |
Primary | Clinical success rate | The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility | 12 months | |
Primary | Radiographic success rate | The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: Normal periodontal ligament space No inter-radicular or periapical radiolucency No internal or external root resorption |
3 months | |
Primary | Radiographic success rate | The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: Normal periodontal ligament space No inter-radicular or periapical radiolucency No internal or external root resorption |
6 months | |
Primary | Radiographic success rate | The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: Normal periodontal ligament space No inter-radicular or periapical radiolucency No internal or external root resorption |
12 months |
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