Back to resultsErbium Chromium: YSGG Laser Effect on Surgical Treatment of Chronic Periodontitis
Primary Purpose
Generalized Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser device Er,Cr:YSGG laser
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- 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 .
Exclusion criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
open flap debridement
laser device with open flap debridement
Arm Description
surgical treatment of periodontal pocket without any intervention
surgical intervention associated with application of Erbium chromium: YSGG laser therapy
Outcomes
Primary Outcome Measures
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.
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
Clinical Assessment of Probing depth (PD).
measured by milli meters for detection of level of periodontal destruction.
Clinical Assessment of Clinical attachment level (CAL) .
measured by milli meters for detection of level of periodontal destruction.
Clinical Assessment of Gingival recession(GR)
measured by milli meters for detection of level of apical migration of gingival attachment.
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03810560
Brief Title
Erbium Chromium: YSGG Laser Effect on Surgical Treatment of Chronic Periodontitis
Official Title
Microbiological and Clinical Assessments of Erbium Chromium: YSGG Laser as an Adjunctive to Surgical Treatment of Chronic Periodontitis (Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
alaa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open flap debridement
Arm Type
No Intervention
Arm Description
surgical treatment of periodontal pocket without any intervention
Arm Title
laser device with open flap debridement
Arm Type
Active Comparator
Arm Description
surgical intervention associated with application of Erbium chromium: YSGG laser therapy
Intervention Type
Device
Intervention Name(s)
laser device Er,Cr:YSGG laser
Intervention Description
laser device with open flap debridement
Primary Outcome Measure Information:
Title
Clinical Assessment of Plaque index(PI)
Description
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.
Time Frame
6 months
Title
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.
Description
Visual Analog Score for gingival inflammation
Time Frame
6 months
Title
Clinical Assessment of Probing depth (PD).
Description
measured by milli meters for detection of level of periodontal destruction.
Time Frame
6 months
Title
Clinical Assessment of Clinical attachment level (CAL) .
Description
measured by milli meters for detection of level of periodontal destruction.
Time Frame
6 months
Title
Clinical Assessment of Gingival recession(GR)
Description
measured by milli meters for detection of level of apical migration of gingival attachment.
Time Frame
6 months
Title
Clinical Assessment of Modified sulcular bleeding index (MSBI)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Microbiological assessment through real time PCR assay for quantification of total bacterial load by universal probe and primer set (16sr RNA)
Description
quantification of total bacterial load
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 .
Exclusion criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Erbium Chromium: YSGG Laser Effect on Surgical Treatment of Chronic Periodontitis
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