Effects of Scaling and Root Planing With and Without Er:YAG Laser in Chronic Periodontitis Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/13/2018 |
| Start Date: | April 20, 2017 |
| End Date: | March 2018 |
| Contact: | Amanda Program Manager |
| Email: | dentalresearchadministration@tufts.edu |
| Phone: | 614-636-2147 |
Randomized Clinical Trial Assessing the Clinical Outcomes and Recolonization Patterns Following Scaling and Root Planing With and Without Using Er.YAG Laser in Chronic Periodontitis Patients
Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal
(gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque
is critical for improving the periodontal health. The standard initial treatment of
periodontitis (gum disease) is to remove plaque and calculus form the teeth and root
structures using sclaing and root planing (SRP). Typically hand instruments and an ultrasonic
scaler are used for SRP
While this method removes some of the bacteria that leads to periodontitis, microorganisms
are not completely eliminated through SRP. Studies have shown that after 3 months, the
bacteria initially present prior to scaling and root planing had recolonized. In order to
prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low
levels.
When used at the proper wave length, dental lasers have been shown to effectively removes
calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for the
use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have shown
that it is effective in removing calculus and preserving the tooth root structure, there is
no consensus of the level of calculus removal. The Er:YAG laser may also be more effective in
removing microbial bacteria than SRP with hand instruments and ultrasonic scaler.
The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an adjunct
to scaling and root planing, in removing microbial bacteria. Participants with chronic
periodontitis will be randomized to have one quadrant undergo scaling and root planing using
hand instruments and ultrasonic scaler alone, while a second quadrant will receive the same
treatment, with the addition of the Er:YAG laser. Outcomes studies will be traditional
periodontal clinical parameters at 6 weeks and 3 months after treatment. Microbial cultures
will be performed at baseline and 3 months to compare survival and re-population by
periodontal microorganisms.
(gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque
is critical for improving the periodontal health. The standard initial treatment of
periodontitis (gum disease) is to remove plaque and calculus form the teeth and root
structures using sclaing and root planing (SRP). Typically hand instruments and an ultrasonic
scaler are used for SRP
While this method removes some of the bacteria that leads to periodontitis, microorganisms
are not completely eliminated through SRP. Studies have shown that after 3 months, the
bacteria initially present prior to scaling and root planing had recolonized. In order to
prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low
levels.
When used at the proper wave length, dental lasers have been shown to effectively removes
calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for the
use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have shown
that it is effective in removing calculus and preserving the tooth root structure, there is
no consensus of the level of calculus removal. The Er:YAG laser may also be more effective in
removing microbial bacteria than SRP with hand instruments and ultrasonic scaler.
The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an adjunct
to scaling and root planing, in removing microbial bacteria. Participants with chronic
periodontitis will be randomized to have one quadrant undergo scaling and root planing using
hand instruments and ultrasonic scaler alone, while a second quadrant will receive the same
treatment, with the addition of the Er:YAG laser. Outcomes studies will be traditional
periodontal clinical parameters at 6 weeks and 3 months after treatment. Microbial cultures
will be performed at baseline and 3 months to compare survival and re-population by
periodontal microorganisms.
Primary Aim: The primary aim of this study is to evaluate the efficacy of Er:YAG laser as an
adjunct to mechanical scaling and root planing periodontal therapy by comparing probing depth
and clinical attachment levels.
Secondary aim: The secondary aim of this study is to evaluate the efficacy of Er:YAG laser as
an adjunct to mechanical scaling and root planing periodontal therapy by comparing gingival
bleeding index and plaque index.
Tertiary aim: The tertiary aim of this study is to compare the microbial outcomes of
mechanical periodontal therapy alone vs. mechanical therapy combined followed with Er:YAG
laser therapy at the same time.
adjunct to mechanical scaling and root planing periodontal therapy by comparing probing depth
and clinical attachment levels.
Secondary aim: The secondary aim of this study is to evaluate the efficacy of Er:YAG laser as
an adjunct to mechanical scaling and root planing periodontal therapy by comparing gingival
bleeding index and plaque index.
Tertiary aim: The tertiary aim of this study is to compare the microbial outcomes of
mechanical periodontal therapy alone vs. mechanical therapy combined followed with Er:YAG
laser therapy at the same time.
Inclusion Criteria:
- Patients enrolled in the Post-Graduate Periodontology Clinic at Tufts University
School of Dental Medicine (TUSDM)
- Recent (within the past 30 days) diagnosis of moderate to severe chronic periodontitis
in at least two quadrants according to the Armitage Classification
- Have had full mouth and vertical bite-wing series of diagnostic radiographs exposed at
TUSDM within 6 months preceding entry of the study as a standard of care
- Have a treatment plan made by the original provider and certified by the PI based on
the working diagnosis, presenting etiology, and the predicted therapeutic outcomes of
the case (prognosis).
- Each of the two selected quadrants should have at least 5 teeth including the canine,
first premolar and second premolar in contact with at least one tooth that has ≥ 5 mms
and ≤ 9 mms probing depths with bleeding on probing.
Exclusion Criteria:
- Participants must not have had mechanical debridement or any other professional
periodontal therapy within 6 months preceding entering the study
- Participants with significant chronic oral soft tissue pathology (lichen planus,
Benign Mucous Membrane Pemphigoid, Steven Johnson's Syndrome, Sjogren's Syndrome,
etc.) which might affect host response to the presence of bacteria.
- Participants with fixed appliances or partial dentures, to standardize the effect of
the treatment since they are plaque retentive.
- Participants who smoke tobacco
- Participants who require prophylactic antibiotics prior to dental treatment
- Participants who have taken systemic antibiotic medications within the previous 6
months
- Participants with uncontrolled systemic conditions or disease such as diabetes and
immunological disorders
- Participants with known drug allergies or known adverse effects following the use of
oral hygiene products.
- Participants who are pregnant or lactating
- Teeth with grade III mobility or teeth with hopeless prognosis indicated for
extraction
We found this trial at
1
site
Boston, Massachusetts 02111
Principal Investigator: Charles Hawley, DDS, MS, PhD
Click here to add this to my saved trials
