Clinical trial NCT04847830: Adjunctive Laser for Periodontal Intrabony Defects
Official title: Effects of Adjunctive Er, Cr :YSGG Laser Treatment to Nonsurgical Periodontal Treatment on Healing of Intrabony Periodontal Defects: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-surgical periodontal therapy with or without laser adjunct
Primary purpose: TREATMENT

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.

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.

Exclusion:

* 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
* Teeth with hopeless prognosis indicated for extraction (Cortellini et al 2011)
* Patients with a non-adequate level of English

Primary outcomes:
measure: Pocket resolution
timeFrame: 12 months
Secondary outcomes:
measure: Gain bone height
timeFrame: 12 months
measure: Patient-related outcomes
timeFrame: 12 months
measure: GCF biomarkers
timeFrame: 12 months
measure: Recession
timeFrame: 12 months
measure: CAL
timeFrame: 12 months
measure: Mobility
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: