Skip to main content
OpenTrials
Completed

NCT Number: NCT03810560

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Generalized Chronic Periodontitis

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Two groups are randomly allocated (random number generation) by Microsoft excel into two groups :

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser device Er,Cr:YSGG laser

Device

laser device with open flap debridement

Primary outcomes

  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

    • plaque only detected by probe.
    • Moderate deposits detected by naked eye.
    • 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.

    • =pin pointed bleeding.
    • = linear bleeding.
    • = Heavy or profuse bleeding.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

alaa

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2019
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.