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

Not Applicable

Completed

• Conditions: Generalized Chronic Periodontitis

• Registration Number: NCT03810560
• Lead Sponsor: alaa

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 :

1. 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.

2. Group (2) Open Flap debridement (OFD) surgery after conventional periodontal therapy (Scaling \&Curettage and root planing) will be performed.

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2019-01
• Study First Submitted: 2019-01-05
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Completion: 2019-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-04
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Assessment of Clinical attachment level (CAL) .	6 months	measured by milli meters for detection of level of periodontal destruction.
Clinical Assessment of Probing depth (PD).	6 months	measured by milli meters for detection of level of periodontal destruction.
Clinical Assessment of Plaque index(PI)	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 recession(GR)	6 months	measured by milli meters for detection of level of apical migration of gingival attachment.
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.	6 months	Visual Analog Score for gingival inflammation
Clinical Assessment of Modified sulcular bleeding index (MSBI)	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.

Secondary Outcome Measures

Name	Time	Method
Microbiological assessment through real time PCR assay for quantification of total bacterial load by universal probe and primer set (16sr RNA)	3 months	quantification of total bacterial load