Periodontal DiseasesNCT04477551
The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis
A study testing Diode laser (device) with scaling and root planing and Conventional scaling and root planing in people with Periodontal Diseases, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Diode laser (device) with scaling and root planing and Conventional scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 28 Jul 2020to 28 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Received periodontal treatment in the last 12 months.
- Received systemic antibiotic in the last 6 months.
- Pregnancy or lactating participants
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Dubai Dental Hospital
Dubai, 505097
Momen A Atieh, BDS, MSc, DClinDent, PhD
About this study
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
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.
Read more
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.
- Conditions
- Periodontal Diseases
- Being tested
- Diode laser (device) with scaling and root planing, Conventional scaling and root planing
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser (device) with scaling and root planingProcedure or surgery
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 planingProcedure or surgery
Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.
| Study group | Role | What they receive |
|---|---|---|
| Diode laser (device) with scaling and root planing | Experimental | Diode laser (device) with conventional scaling and root planing Receives: Procedure: Diode laser (device) with scaling and root planing |
| Conventional scaling and root planing | Active comparator | Conventional scaling and root planing Receives: Procedure: Conventional scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline FMPS at six months
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.
Measured: Change from baseline FMBS at six months
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.
Measured: Change from baseline PPDs at six months
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.
Measured: Change from baseline CALs at six months
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.
Measured: Change from baseline number of sites with PPDs ≥ 6 mm at six months
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.
Measured: Change from baseline percentages of sites with PPDs ≥ 6 mm at six months
Secondary outcomes (7)
Operating time
Time required to complete the procedure
Measured: Outcome measures will be recorded at baseline
Postoperative pain
Patient-related outcomes (pain) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Measured: Change from baseline pain at seven days
Postoperative swelling
Patient-related outcomes (swelling) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Measured: Change from baseline swelling at seven days
Postoperative bleeding
Patient-related outcomes (bleeding) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Measured: Change from baseline bleeding at seven days
Postoperative bruising
Patient-related outcomes (bruising) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Measured: Change from baseline bruising at seven days
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
Measured: Change from baseline root sensitivity at seven days
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.
Measured: Change from baseline GOHAI score at six months days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start28 Jul 2020
- Primary completion28 Oct 2022 (estimated)
- Study completion28 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Associate Professor Momen Atieh, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477551
- Sponsor's protocol ID
- MBRU/IRB/2020/006
- Status last verified
- Sep 2021
- First submitted
- 3 Jul 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04477551
- Acronym / sponsor ID
- MBRU/IRB/2020/006
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 28 Oct 2022 (estimated)
- Study completion
- 28 Oct 2023 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode laser (device) with scaling and root planing | Experimental | Procedure: Diode laser (device) with scaling and root planingDiode laser (device) with conventional scaling and root planing |
| Conventional scaling and root planing | Active comparator | Procedure: Conventional scaling and root planingConventional scaling and root planing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Received periodontal treatment in the last 12 months.
- Received systemic antibiotic in the last 6 months.
- Pregnancy or lactating participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode laser (device) with scaling and root planingCombined use of diode laser device and scaling instruments to remove plaque and calculus from the surface of the roots of teeth. | Procedure or surgery | Diode laser (device) with scaling and root planing |
| Conventional scaling and root planingUse of scaling instruments to remove plaque and calculus from the surface of the roots of teeth. | Procedure or surgery | Conventional scaling and root planing |
Primary outcome
Full mouth plaque score (FMPS).
Time frame: Change from baseline FMPS at six months
The plaque score is calculated by expressing as a percentage the number of surfaces harbouring plaque related to the total number of tooth surfaces.
Full mouth bleeding score (FMBS).
Time frame: Change from baseline FMBS at six months
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.
Probing pocket depth (PPD).
Time frame: Change from baseline PPDs at six months
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.
Clinical attachment level (CAL).
Time frame: Change from baseline CALs at six months
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.
Number of sites PPDs ≥ 6 mm.
Time frame: Change from baseline number of sites with PPDs ≥ 6 mm at six months
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.
Percentages of sites PPDs ≥ 6 mm.
Time frame: Change from baseline percentages of sites with PPDs ≥ 6 mm at six months
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.
7 secondary outcomes
Operating time
Time frame: Outcome measures will be recorded at baseline
Postoperative pain
Time frame: Change from baseline pain at seven days
Postoperative swelling
Time frame: Change from baseline swelling at seven days
Postoperative bleeding
Time frame: Change from baseline bleeding at seven days
Postoperative bruising
Time frame: Change from baseline bruising at seven days
Postoperative root sensitivity
Time frame: Change from baseline root sensitivity at seven days
Quality of life measures
Time frame: Change from baseline GOHAI score at six months days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser (device) with scaling and root planing and Conventional scaling and root planing in people with Periodontal Diseases, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Momen A Atieh, BDS, MSc, DClinDent, PhD (+97143838905, momen.atieh@mbru.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full mouth plaque score (FMPS). (time frame: Change from baseline FMPS at six months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.