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

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ClinicalTrials.gov Identifier: NCT03810560
Recruitment Status : Active, not recruiting
First Posted : January 18, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Alaa Hashim, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Generalized Chronic Periodontitis Device: laser device Er,Cr:YSGG laser Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Microbiological and Clinical Assessments of Erbium Chromium: YSGG Laser as an Adjunctive to Surgical Treatment of Chronic Periodontitis (Randomized Clinical Trial)
Actual Study Start Date : December 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Clinical Assessment of Plaque index(PI) [ Time Frame: 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.

  2. 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. [ Time Frame: 6 months ]
    Visual Analog Score for gingival inflammation

  3. Clinical Assessment of Probing depth (PD). [ Time Frame: 6 months ]
    measured by milli meters for detection of level of periodontal destruction.

  4. Clinical Assessment of Clinical attachment level (CAL) . [ Time Frame: 6 months ]
    measured by milli meters for detection of level of periodontal destruction.

  5. Clinical Assessment of Gingival recession(GR) [ Time Frame: 6 months ]
    measured by milli meters for detection of level of apical migration of gingival attachment.

  6. Clinical Assessment of Modified sulcular bleeding index (MSBI) [ Time Frame: 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 :
  1. Microbiological assessment through real time PCR assay for quantification of total bacterial load by universal probe and primer set (16sr RNA) [ Time Frame: 3 months ]
    quantification of total bacterial load



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Responsible Party: Alaa Hashim, Teaching Assistant, Ain Shams University
ClinicalTrials.gov Identifier: NCT03810560     History of Changes
Other Study ID Numbers: PER16-30M
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chromium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs