A comparative study of autogenous bone graft use with and without low-level laser therapy in the treatment of the two and three wall intrabony periodontal defects
The purpose of this study was to compare the use of autogenous bone alone and in combination with Low-level laser therapy (LLLT) in the treatment of two and three wall periodontal intrabony defects in human. Study population: Referred patients to the periodontics department of Tabriz university of medical sciences from May 2011 to December 2011. Sample size: 15. Inclusion criteria: Patient with moderate to severe generalized chronic periodontitis with at least two similar infra-bony defects in the interproximal region with probing depth greater or equal to 5 mm and lesion depth of equal to or greater than 3 mm. Exclusion criteria: Presence of systemic disease interfering with periodontal surgery or healig; smoking. Intervention and timing: Low-level laser therapy during pocket regenerative therapy. Primay outcome: Clinical attachment level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207019121N2
Registration date:2012-07-22, 1391/05/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-22, 1391/05/01
Registrant information
Name
Mehrnaz Sadighi Shamami
Name of organization / entity
Dental faculty, Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
m.sedighi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental faculty, Tabriz university of medical sciences
Expected recruitment start date
2011-05-01, 1390/02/11
Expected recruitment end date
2012-12-04, 1391/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of autogenous bone graft use with and without low-level laser therapy in the treatment of the two and three wall intrabony periodontal defects
Public title
The effect of bone graft use with low-level laser therapy in the treatment of periodontal disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Full mouth plaque index (FMPI) <= 20%; the percentage of the areas which are bleeding within 30 seconds after the probe be less than or equal to 20%; in the radiographic assessment which was confirmed with bone sounding, each patient has at least one pair similar infra-bony defects in the interproximal region with probing depth greater or equal to 5 mm and lesion depth of equal to or greater than 3 mm. Exclusion criteria: presence of systemic disease interfering with periodontal surgery or healig; smoking; trauma from occlusion; prolonged use of drugs interfering with bone metabolism; pregnancy and lactation; antibiotic use during study or in the past 6 months.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
15 patients with moderate to severe chronic periodontitis with bilateral intrabony defects are included. In a split mouth study design, 15 defects are treated by OFD and autogenous bone while others receive low-level laser therapy as an adjunct treatment. A GaAlAs diode laser is used. Soft and hard tissue variables are recorded relative to an acrylic stent at baseline and after 3 months.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical sciences ethic commitee
Street address
Tabriz university of medical sciences, Golgasht avenue
City
Tabriz
Postal code
Approval date
2012-06-09, 1391/03/20
Ethics committee reference number
9147
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic pericoronitis
Primary outcomes
1
Description
bone fill of the intrabony defect
Timepoint
baseline, three months later
Method of measurement
UNC-15 probe
Secondary outcomes
1
Description
clinical attachment level
Timepoint
baseline, 3 months
Method of measurement
UNC 15
Intervention groups
1
Description
Control group: Regenerative surgery under local anesthesia of Lidocaine 2% with epinephrine 1/80000- sulcular incision in baccal and lingual aspects and debridement of the lesion with hand instruments and ultrasonic devices- use of autogenous bone graft in the bone defect.
Category
Treatment - Surgery
2
Description
Intervention in test group: Regenerative surgery under local anesthesia of Lidocaine 2% with epinephrine 1/80000- sulcular incision in baccal and lingual aspects and debridement of the lesion with hand instruments and ultrasonic devices- use of autogenous bone graft in the bone defect and laser use following suturing with the following parameters: GaAlAs laser with continuous wave and 40 mw power and energy fluence of 4 J/cm2 and total energy of 16 J/cm2 with 1 cm distance from the covering soft tissue.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty, Tabriz university of medical sciences
Full name of responsible person
Mehrnoosh Sadighi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Mohamadreza Rashidi
Street address
vice-chancellor for research, 2nd floor, adminstrative building of Tabriz university of medical sciences, Golgasht avenue, Abresan square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?