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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Chronic Periodontitis
• Intervention / Treatment: Device: laser device Er,Cr:YSGG laser

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: alaa

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: January 5, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 4, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: PER16-30M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No