CTRI Number |
CTRI/2017/09/009736 [Registered on: 12/09/2017] Trial Registered Prospectively |
Last Modified On: |
12/09/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Treating gum diseases using LASER |
Scientific Title of Study
|
Comparative evaluation of Laser-Assisted New Attachment procedure and Excisional New Attachment procedure for the treatment of Periodontal Pockets. A Randomised Split Mouth Clinical Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Avuluri Joshna |
Designation |
Post Graduate |
Affiliation |
Narayana Dental College and Hospital |
Address |
Department of Periodontology, Narayana Dental College and Hospital, Chithareddypalem,
Nellore 524003
Andhra Pradesh
INDIA
Nellore ANDHRA PRADESH 524003 India |
Phone |
8500787824 |
Fax |
|
Email |
avuluri.joshna@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sreenivas Nagarakanti |
Designation |
Professor |
Affiliation |
Narayana Dental College and Hospital |
Address |
Department of Periodontology, Narayana Dental College and Hospital, Chithareddypalem,
Nellore 524003
AndhraPradesh
INDIA
Nellore ANDHRA PRADESH 524003 India |
Phone |
9985664566 |
Fax |
|
Email |
sreenivasnagarakanti@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sreenivas Nagarakanti |
Designation |
Professor |
Affiliation |
Narayana Dental College and Hospital |
Address |
Department of Periodontology, Narayana Dental College and Hospital, Chithareddypalem,
Nellore 524003
Andhra Pradesh
INDIA
Nellore ANDHRA PRADESH 524003 India |
Phone |
9985664566 |
Fax |
|
Email |
sreenivasnagarakanti@gmail.com |
|
Source of Monetary or Material Support
|
Self Funded
(Principal Investigator) Dr.Avuluri Joshna, Department of Periodontology,
Narayana Dental College and Hospital,
Chithareddypalem,
Nellore 524003
Andhra Pradesh
INDIA
|
|
Primary Sponsor
|
Name |
NIL |
Address |
NIL |
Type of Sponsor |
Other [NIL] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Avuluri Joshna |
Narayana Dental College and Hospital |
Room Number 5,
Department of Periodontology
Narayana Dental College and Hospital,
Chithareddypalem,
Nellore, Pin 524003 Nellore ANDHRA PRADESH |
8500787824
avuluri.joshna@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, Narayana Dental College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Systemically healthy |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Excisional New Attachment Procedure |
After scaling and root planning, under adequate local anaesthesia pocket marking will be performed to delineate the depth of the incision. A scalloped, internally-bevelled, partial thick-ness incision will be made from crest of the free gingival margin to the base of pocket in the area being treated. The excised tissue and all of the granulomatous tissue within the area of the pocket will be removed with a curette. The root surfaces are then scaled and planed to a smooth, hard consistency to the base of incision. The gingival tissue is then repositioned against the tooth as closely as possible and if required the wound edges should be secured with sutures and periodontal dressing |
Intervention |
Laser Assisted New Attachment Procedure |
After scaling and root planning, diode laser will be first used on a setting of 4.0 W, 100-microseconds pulse duration, and 20 Hz. It is passed from gingival margin to the base of the pocket parallel to the root surface and moved laterally and apically to remove the diseased pocket epithelium and decontaminate the pocket. A second pass with the laser on to the setting of 4.0 W, 650-microseconds pulse duration, and 20 Hz was performed to form a fibrin clot and then the tissue will be compressed against the tooth for closer approximation. |
Comparator Agent |
Scaling and Root Planning |
Scaling and Root Planning with ultrasonic scalers |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
The individuals aged 25 to 60 years.
Subjects with at least 20 natural permanent teeth
History of no periodontal treatment in last 12 months
Should have at least probing depth equal to or more than 5mm
|
|
ExclusionCriteria |
Details |
Systemic diseases that could influence the outcome of periodontal therapy
Smokers
Pregnancy and Lactating women.
Poor oral hygiene and failure to comply with protocol
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the clinical outcomes of LANAP versus ENAP and SRP procedures among study population. |
1 month, 3 months, 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare patients response following ENAP and LANAP |
1 month |
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
|
02/10/2017 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
AIM: The aim of the present study is to
evaluate the clinical effect of laser assisted new attachment procedure versus excisional
new attachment procedure in the treatment of moderate periodontal pockets. METHOD: All the patients will be explained about
the aim, nature, and design of the study along with a written informed consent
for their participation before the commencement of the study. The
study is planned as a single centre, longitudinal, triple masked (investigators,
subjects and statistician), randomized parallel arm design. The study duration
is 6 months in which the clinical parameters will be recorded at baseline, 1
month, 3 months, 6 months The clinical parameters for consideration
includes plaque index (Silness and Loe 1964), gingival bleeding index (Muehlemann
and Son 1971), pocket depth and clinical attachment level, and healing index(landry,Turnbull and Howley),
VAS Three
sites with pocket depth of 5 mm or above will be selected for the study. The
selected sites will be randomized into
three groups. (Group A, B & C). The randomization will be done using a
computer generated random table Group A (control site): SRP Group B (test site): SRP with ENAP Group C (test site): SRP with LANAP TREATMENT
PROCEDURE:
ENAP: After scaling and root planning, under
adequate local anaesthesia pocket marking will be performed to delineate the
depth of the incision. A scalloped, internally-bevelled, partial thick-ness
incision will be made from crest of the free gingival margin to the base of
pocket in the area being treated. The excised tissue and all of the
granulomatous tissue within the area of the pocket will be removed with a
curette. The root surfaces are then scaled and planed to a smooth, hard
consistency to the base of incision. The gingival tissue is then repositioned
against the tooth as closely as possible and if required the wound edges should
be secured with sutures and periodontal dressing.
LANAP:
After scaling and root planning, diode laser will be first used on a setting of
4.0 W, 100-microseconds pulse duration, and 20 Hz. It is passed from gingival
margin to the base of the pocket parallel to the root surface and moved
laterally and apically to remove the diseased pocket epithelium and
decontaminate the pocket. A second pass with the laser on to the setting of 4.0
W, 650-microseconds pulse duration, and 20 Hz was performed to form a fibrin
clot and then the tissue will be compressed against the tooth for closer approximation.
|