Adjunctive Laser for Periodontal Intrabony Defects
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Periodontitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: non-surgical periodontal therapy with or without laser adjunctMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Randomisation for the site receiving the additional test procedure (laser) will be carried out between baseline and visit 2. The randomisation will be carried out by Postgraduate Students independent of the study. Random permuted block sizes of 4 will be employed. The centralised randomisation service 'Sealed envelope' will be used for randomisation and to ensure allocation concealment. A sealed envelope will be enclosed with the patient's notes by personnel not directly involved in the study. The therapist will only be informed about treatment allocation by opening the envelope following completion of non-surgical therapy (when the laser will need to be employed on the test site). No minimization or stratification is planned. The randomisation code will only be revealed after statistical analysis. The randomisation will be done by a different postgraduate student who will be masked and is not involved in the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
The study is a Double-masked randomised controlled trial with split-mouth design. Participants with periodontitis will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same t...
The study is a Double-masked randomised controlled trial with split-mouth design. Participants with periodontitis will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be periodontal clinical parameters at 3 months, 6 months, 9 months and 12 months after treatment, radiographic parameters at 12 months, patient-reported parameters and laboratory analyses.
Tracking Information
- NCT #
- NCT04847830
- Collaborators
- Not Provided
- Investigators
- Not Provided
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