The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis

Periodontal Diseases Clinical Trial

Official title:

The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04477551
• Other study ID #: MBRU/IRB/2020/006
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: October 28, 2023

Study information

• Verified date: September 2021
• Source: Mohammed Bin Rashid University of Medicine and Health Sciences
• Contact: Momen A Atieh, BDS, MSc, DClinDent, PhD
• Phone: +97143838905
• Email: momen.atieh[@]mbru.ac.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Periodontal disease is serious and global chronic disease. The prevalence of periodontal diseases in United Arab Emirates is not clear but data from Dubai Health Authority showed that one in five patients has received periodontal treatment in recent years.

Several studies reported the additional benefits provided by the use of diode laser in combination with ultrasonic debridement in the treatment of gum disease. The use of diode laser may debridement of deep pocketing areas while improving healing of gum tissues.

The aim of the study is to compare the effect of removing bacterial deposit (biofilm) from deep tooth pocket using combined diode laser and conventional pocket debridement versus conventional pocket debridement alone on tooth supporting tissue parameters in patients with advanced gum disease (periodontitis).

Methodology: A total of 22 patients with advanced gum disease will be randomly allocated to two groups: a control group, which will receive conventional pocket debridement and a test group which will receive ultrasonic debridement with diode laser. Gum measurements will be recorded by a masked calibrated examiner at six points for each tooth and patients' postoperative experience and satisfaction will be assessed using special forms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: October 28, 2023
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 or over.

• Diagnosed with unstable generalised periodontitis, stage III-IV and grade B or C.

• Good compliance and commitment to attend follow-up review appointments.

• Willing to provide informed consent.

Exclusion Criteria:

• Received periodontal treatment in the last 12 months.

• Received systemic antibiotic in the last 6 months.

• Pregnancy or lactating participants

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Procedure:
• Diode laser (device) with scaling and root planing
Combined use of diode laser device and scaling instruments to remove plaque and calculus from the surface of the roots of teeth.
• Conventional scaling and root planing
Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.

Locations

Country	Name	City	State
United Arab Emirates	Dubai Dental Hospital	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed Bin Rashid University of Medicine and Health Sciences

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full mouth plaque score (FMPS).	The plaque score is calculated by expressing as a percentage the number of surfaces harbouring plaque related to the total number of tooth surfaces.	Change from baseline FMPS at six months
Primary	Full mouth bleeding score (FMBS).	The bleeding score is calculated by expressing as a percentage the number of sites that bleed upon probing in relation to the total number of tooth sites.	Change from baseline FMBS at six months
Primary	Probing pocket depth (PPD).	PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.	Change from baseline PPDs at six months
Primary	Clinical attachment level (CAL).	CAL is calculated from a fixed reference point (cementoenamel junction or CEJ), and it is computed by calculating the distance from the CEJ to the base of the pocket in millimeters.	Change from baseline CALs at six months
Primary	Number of sites PPDs = 6 mm.	Number of sites with PPDs = 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.	Change from baseline number of sites with PPDs = 6 mm at six months
Primary	Percentages of sites PPDs = 6 mm.	Percentages of sites with PPDs = 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.	Change from baseline percentages of sites with PPDs = 6 mm at six months
Secondary	Operating time	Time required to complete the procedure	Outcome measures will be recorded at baseline
Secondary	Postoperative pain	Patient-related outcomes (pain) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome	Change from baseline pain at seven days
Secondary	Postoperative swelling	Patient-related outcomes (swelling) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome	Change from baseline swelling at seven days
Secondary	Postoperative bleeding	Patient-related outcomes (bleeding) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome	Change from baseline bleeding at seven days
Secondary	Postoperative bruising	Patient-related outcomes (bruising) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome	Change from baseline bruising at seven days
Secondary	Postoperative root sensitivity	Patient-related outcomes (root sensitivity) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome	Change from baseline root sensitivity at seven days
Secondary	Quality of life measures	Patient's quality of life will be evaluated using general oral health assessment index (GOHAI). The GOHAI has 12 negatively and positively worded items evaluating three dimensions of oral health related quality of life (physical function, pain or discomfort and psychosocial function).; The score ranged from 0 to 60. The scores are maintained for the three items "able to swallow comfortably", able to eat without discomfort", "pleased with look of teeth", and reversed for the remaining nine items, so that a higher score was associated with a more positive oral health.	Change from baseline GOHAI score at six months days