NCT03810560

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

January 5, 2019

Last Update Submit

March 4, 2023

Conditions

Generalized Chronic Periodontitis

Outcome Measures

Primary Outcomes (6)

  • 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 1. plaque only detected by probe. 2. Moderate deposits detected by naked eye. 3. 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. 1. =pin pointed bleeding. 2. = linear bleeding. 3. = Heavy or profuse bleeding.

    6 months

Secondary Outcomes (1)

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

    3 months

Study Arms (2)

open flap debridement

NO INTERVENTION

surgical treatment of periodontal pocket without any intervention

laser device with open flap debridement

ACTIVE COMPARATOR

surgical intervention associated with application of Erbium chromium: YSGG laser therapy

Device: laser device Er,Cr:YSGG laser

Interventions

laser device Er,Cr:YSGG laserDEVICE

laser device with open flap debridement

laser device with open flap debridement

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients are diagnosed to have chronic periodontitis, having infrabony posterior periodontal pocket measuring 5 mm or more.
  • female or male.
  • years.
  • Medically controlled according to medical coding of review of systems .
  • Patient without history of drug administration in last month .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

January 5, 2019

First Posted

January 18, 2019

Study Start

December 1, 2016

Primary Completion

January 1, 2019

Study Completion

April 1, 2019

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share