Effects of Adjunctive Er, Cr :YSGG Laser Treatment to Nonsurgical Periodontal Treatment on Healing of Intrabony Periodontal Defects: a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periodontitis
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Enrollment
- 28
- Primary Endpoint
- Pocket resolution
- Last Updated
- 5 years ago
Overview
Brief Summary
Participants with periodontitis and presence of bilateral intrabony defect 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.
Detailed 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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Minimum of 20 teeth. Diagnosis of Severe Periodontitis (Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)
- •Presence of at least 2 teeth with ≥ 6 mm pockets and minimum of 3 mm intrabony defect, in opposing quadrants of the upper or lower arch.
Exclusion Criteria
- •Inclusion:
- •Minimum of 20 teeth. Diagnosis of Severe Periodontitis (Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)
- •Presence of at least 2 teeth with ≥ 6 mm pockets and minimum of 3 mm intrabony defect, in opposing quadrants of the upper or lower arch.
- •Wearing of a removable appliance/denture
- •Wearing of orthodontic appliances.
- •Current smoking - any history of smoking or vaping within last 5 years
- •Relevant medical history likely to affect periodontal disease or taking relevant medication, including diabetes, as judged by the examining clinician
- •Periodontal treatment (surgical/non-surgical root surface debridement under local anaesthesia) within last 12 months, as judged by the examining clinician
- •History of any antibiotic use within last 3 months.
- •Pregnant patients
Outcomes
Primary Outcomes
Pocket resolution
Time Frame: 12 months
Number of sites with absence of PPD \>5mm following adjunctive laser treatment with RSD (= no need for surgery)
Secondary Outcomes
- Recession(12 months)
- Gain bone height(12 months)
- Patient-related outcomes(12 months)
- GCF biomarkers(12 months)
- CAL(12 months)
- Mobility(12 months)