Adjunctive Laser for Periodontal Intrabony Defects

NCT04847830 | Unknown

• 1 other identifier: 276918
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Pocket resolution

  Number of sites with absence of PPD \>5mm following adjunctive laser treatment with RSD (= no need for surgery)

  12 months

Secondary Outcomes (6)

• Gain bone height

  12 months

• Patient-related outcomes

  12 months

• GCF biomarkers

  12 months

• Recession

  12 months

• CAL

  12 months

Study Arms (2)

Laser

EXPERIMENTAL

One side of the mouth will undergo root surface debridement using hand instruments and ultrasonic scaler, with the addition of the Er:YAG laser

Device: Er:YAG laser (Waterlase); Procedure: root surface dbridement

Control

PLACEBO COMPARATOR

The other side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone

Procedure: root surface dbridement

Interventions

Er:YAG laser (Waterlase) DEVICE

The WaterLase iPlus tissue cutting system is a unique device with diverse, hard- and soft-tissue dental applications. It utilizes advanced laser and water atomization technologies to safely and effectively cut, shave, contour, roughen, etch, and resect oral hard-tissue, and direct laser energy to perform oral soft-tissue removal, incision, excision, ablation and coagulation.

Laser

root surface dbridement PROCEDURE

root surface debridement under local anaesthesia

Control; Laser

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Periodontitis

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Luigi Nibali

CONTACT

0044 2071887188; luigi.nibali@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-surgical periodontal therapy with or without laser adjunct

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 19, 2021
• Study Start: April 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share