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

Generalized Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810560
• Other study ID #: PER16-30M
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: April 2019

Study information

• Verified date: March 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Generalized Chronic Periodontitis
• Periodontitis

Intervention

Device:
• laser device Er,Cr:YSGG laser
laser device with open flap debridement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
alaa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Clinical Assessment of Probing depth (PD).	measured by milli meters for detection of level of periodontal destruction.	6 months
Primary	Clinical Assessment of Clinical attachment level (CAL) .	measured by milli meters for detection of level of periodontal destruction.	6 months
Primary	Clinical Assessment of Gingival recession(GR)	measured by milli meters for detection of level of apical migration of gingival attachment.	6 months
Primary	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	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