Generalized Chronic PeriodontitisNCT03810560
Erbium Chromium: YSGG Laser Effect on Surgical Treatment of Chronic Periodontitis
A study testing laser device Er,Cr:YSGG laser in people with Generalized Chronic Periodontitis, run by alaa.
Trial summary
Microbiological and Clinical assessment of Er,Cr:YSGG laser in conjunction to open flap debridement (OFD) in treatment of chronic periodontitis through real time PCR assay for quantification of total bacterial load. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Chronic Periodontitis
- What is being tested?
- laser device Er,Cr:YSGG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Apr 2019
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients are diagnosed to have chronic periodontitis, having infrabony posterior periodontal pocket measuring 5 mm or more.
- female or male.
- 25 - 55 years.
- Medically controlled according to medical coding of review of systems .
- Patient without history of drug administration in last month .
Who cannot join
- Tobacco smoking.
- Pregnancy.
- Patients not follow periodontal hygienic instructions.
- Patients under any medication that affect periodontal healing.
- The presence of any systemic disease that affect periodontal healing.
About this study
Official title: Microbiological and Clinical Assessments of Erbium Chromium: YSGG Laser as an Adjunctive to Surgical Treatment of Chronic Periodontitis (Randomized Clinical Trial)
Microbiological and Clinical assessment of Er,Cr:YSGG laser in conjunction to open flap debridement (OFD) in treatment of chronic periodontitis through real time PCR assay for quantification of total bacterial load.
Read the detailed description
Two groups are randomly allocated (random number generation) by Microsoft excel into two groups :
- Group (1) Open Flap debridement (OFD) surgery after conventional periodontal therapy (Scaling \&Curettage and root planing) combined by Er,Cr:YSGG Laser assisted pocket therapy (ELAPT) which will be applied to pocket epithelial lining and root surface.
- Group (2) Open Flap debridement (OFD) surgery after conventional periodontal therapy (Scaling \&Curettage and root planing) will be performed.
- Conditions
- Generalized Chronic Periodontitis
- Being tested
- laser device Er,Cr:YSGG laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser device Er,Cr:YSGG laserDevice
laser device with open flap debridement
| Study group | Role | What they receive |
|---|---|---|
| open flap debridement | No intervention | surgical treatment of periodontal pocket without any intervention |
| laser device with open flap debridement | Active comparator | surgical intervention associated with application of Erbium chromium: YSGG laser therapy Receives: Device: laser device Er,Cr:YSGG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment of Plaque index(PI)
Visual Analog Score for plaque for detection amount of plaque accumulation so assess patient oral hygiene.
recording is based on both soft and mineralized debris. Each surface will have a score from 0 to 3. 0: no plaque
- plaque only detected by probe.
- Moderate deposits detected by naked eye.
- heavy deposits detected by naked eye.
Measured: 6 months
Clinical Assessment of Gingival index(GI) to assess gingival inflammation. 0: normal gingiva. 1: mild inflammation . 2: moderate inflammation . 3: sever inflammation marked redness and edema and spontaneous bleeding.
Visual Analog Score for gingival inflammation
Measured: 6 months
Clinical Assessment of Probing depth (PD).
measured by milli meters for detection of level of periodontal destruction.
Measured: 6 months
Clinical Assessment of Clinical attachment level (CAL) .
measured by milli meters for detection of level of periodontal destruction.
Measured: 6 months
Clinical Assessment of Gingival recession(GR)
measured by milli meters for detection of level of apical migration of gingival attachment.
Measured: 6 months
Clinical Assessment of Modified sulcular bleeding index (MSBI)
Visual Analog Score of bleeding for detection of inflammatory status level. Modified Sulcus Bleeding Index(MSBI) 0 = No bleeding on bleeding.
- =pin pointed bleeding.
- = linear bleeding.
- = Heavy or profuse bleeding.
Measured: 6 months
Secondary outcomes (1)
Microbiological assessment through real time PCR assay for quantification of total bacterial load by universal probe and primer set (16sr RNA)
quantification of total bacterial load
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study startDec 2016
- Primary completionJan 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Chronic PeriodontitisStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- alaa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, alaa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810560
- Sponsor's protocol ID
- PER16-30M
- Status last verified
- Mar 2023
- First submitted
- 5 Jan 2019
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological and Clinical Assessments of Erbium Chromium: YSGG Laser as an Adjunctive to Surgical Treatment of Chronic Periodontitis (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03810560
- Acronym / sponsor ID
- PER16-30M
- Conditions
- Generalized Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- alaaUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 18 Jan 2019 (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.
Microbiological and Clinical assessment of Er,Cr:YSGG laser in conjunction to open flap debridement (OFD) in treatment of chronic periodontitis through real time PCR assay for quantification of total bacterial load.
Detailed description
Two groups are randomly allocated (random number generation) by Microsoft excel into two groups :
- Group (1) Open Flap debridement (OFD) surgery after conventional periodontal therapy (Scaling \&Curettage and root planing) combined by Er,Cr:YSGG Laser assisted pocket therapy (ELAPT) which will be applied to pocket epithelial lining and root surface.
- Group (2) Open Flap debridement (OFD) surgery after conventional periodontal therapy (Scaling \&Curettage and root planing) will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open flap debridement | No intervention | –surgical treatment of periodontal pocket without any intervention |
| laser device with open flap debridement | Active comparator | Device: laser device Er,Cr:YSGG lasersurgical intervention associated with application of Erbium chromium: YSGG laser therapy |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients are diagnosed to have chronic periodontitis, having infrabony posterior periodontal pocket measuring 5 mm or more.
- female or male.
- 25 - 55 years.
- Medically controlled according to medical coding of review of systems .
- Patient without history of drug administration in last month .
Key exclusion criteria (5 listed)
- Tobacco smoking.
- Pregnancy.
- Patients not follow periodontal hygienic instructions.
- Patients under any medication that affect periodontal healing.
- The presence of any systemic disease that affect periodontal healing.
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 |
|---|---|---|
| laser device Er,Cr:YSGG laserlaser device with open flap debridement | Device | laser device with open flap debridement |
Primary outcome
Clinical Assessment of Plaque index(PI)
Time frame: 6 months
Visual Analog Score for plaque for detection amount of plaque accumulation so assess patient oral hygiene. recording is based on both soft and mineralized debris. Each surface will have a score from 0 to 3. 0: no plaque 1. plaque only detected by probe. 2. Moderate deposits detected by naked eye. 3. heavy deposits detected by naked eye.
Clinical Assessment of Gingival index(GI) to assess gingival inflammation. 0: normal gingiva. 1: mild inflammation . 2: moderate inflammation . 3: sever inflammation marked redness and edema and spontaneous bleeding.
Time frame: 6 months
Visual Analog Score for gingival inflammation
Clinical Assessment of Probing depth (PD).
Time frame: 6 months
measured by milli meters for detection of level of periodontal destruction.
Clinical Assessment of Clinical attachment level (CAL) .
Time frame: 6 months
measured by milli meters for detection of level of periodontal destruction.
Clinical Assessment of Gingival recession(GR)
Time frame: 6 months
measured by milli meters for detection of level of apical migration of gingival attachment.
Clinical Assessment of Modified sulcular bleeding index (MSBI)
Time frame: 6 months
Visual Analog Score of bleeding for detection of inflammatory status level. Modified Sulcus Bleeding Index(MSBI) 0 = No bleeding on bleeding. 1. =pin pointed bleeding. 2. = linear bleeding. 3. = Heavy or profuse bleeding.
1 secondary outcome
Microbiological assessment through real time PCR assay for quantification of total bacterial load by universal probe and primer set (16sr RNA)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laser device Er,Cr:YSGG laser in people with Generalized Chronic Periodontitis, run by alaa.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Assessment of Plaque index(PI) (time frame: 6 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 7 Mar 2023.