Erbium Chromium: YSGG Laser Effect on Surgical Treatment of Chronic Periodontitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Microbiological and Clinical Assessments of Erbium Chromium: YSGG Laser as an Adjunctive to Surgical Treatment of Chronic Periodontitis (Randomized Clinical Trial)

Conditions
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Generalized Chronic Periodontitis

Intervention / Treatment
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* Device: laser device Er,Cr:YSGG laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: open flap debridement<br>surgical treatment of periodontal pocket without any intervention | |
| Active Comparator: laser device with open flap debridement<br>surgical intervention associated with application of Erbium chromium: YSGG laser therapy | Device: laser device Er,Cr:YSGG laser<br>* laser device with open flap debridement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 6 months | 
| Clinical Assessment of Probing depth (PD). | measured by milli meters for detection of level of periodontal destruction. | 6 months | 
| Clinical Assessment of Clinical attachment level (CAL) . | measured by milli meters for detection of level of periodontal destruction. | 6 months | 
| Clinical Assessment of Gingival recession(GR) | measured by milli meters for detection of level of apical migration of gingival attachment. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months |