Comparing the effect of preparing implant site with piezosurgery and conventional drilling on patient’s post-operative pain and its effect on stability and bone loss around implants after 5 month period follow up
30 patient candidate for implant placement in two lateral quadrants are selected for this study.half of the implant osteotomy sites are randomly prepared by conventional drilling and the other half are prepared using piezosurgery. all the surgeries are done by the same operator.after implant placement the patients are given the same analgesic order.post operative pain will be evaluated in days 1, 3 and 10 after the surgery using a VAS (Visual Analogue Scale).The implant stability would also be measured using a Osstell Mentor device at the baseline and days 90 and 150.radiographic evaluation would be done at baseline and 5 months after implant placement using parallel technique. the distance between the implant shoulder and the most coronally point of the bone-implant contact would be recorded at baseline and 5 months later. the difference is considered as marginal bone loss.finally a comparison of all the three parameters would be done between the two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041524622N3
Registration date:2016-04-30, 1395/02/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-30, 1395/02/11
Registrant information
Name
Samareh Kafilzadeh
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 9991
Email address
s.kafilzadeh@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamendan University of medical sciences
Expected recruitment start date
2016-04-01, 1395/01/13
Expected recruitment end date
2017-02-01, 1395/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of preparing implant site with piezosurgery and conventional drilling on patient’s post-operative pain and its effect on stability and bone loss around implants after 5 month period follow up
Public title
the effect of using piezosurgery for implant placement on post operative pain, implant stability and bone loss of implants during a 5 moths period
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for implant placement in two lateral quadrants; implant placement should be at least 6 months after tooth extraction; No GBR(Guided bone regeneration) needed around implants; patients with no systemic disease; non smoker patients; No antibiotics or drugs should be taken during the last two months
Exclusion Criteria: implants placed in the same sextant; implants placed in different bone densities; patients with systemic disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences Ethics Committee
Street address
Hamedan- University of Medical Sciences
City
Hamedan
Postal code
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
IR.UMSHA.REC.1394.513
Health conditions studied
1
Description of health condition studied
Implant treatment
ICD-10 code
K08.1
ICD-10 code description
Loss of teeth due to accident, extraction or local periodontal disease
Primary outcomes
1
Description
pain
Timepoint
first day after surgery
Method of measurement
using a Visual Analogue Scale (VAS)
2
Description
Implant stability
Timepoint
Surgery day
Method of measurement
using a Osstell Mentor device
3
Description
Marginal bone loss
Timepoint
Surgery day
Method of measurement
Periapical radiography
Secondary outcomes
1
Description
Pain
Timepoint
day 3 after the surgery
Method of measurement
using a Visual Analogue Scale (VAS)
2
Description
Pain
Timepoint
day 10 after the surgery
Method of measurement
using a Visual Analogue Scale (VAS)
3
Description
Implant Stability
Timepoint
Day 90 after the surgery
Method of measurement
Using Osstell Mentor device
4
Description
Implant Stability
Timepoint
Day 150 after the surgery
Method of measurement
Using Osstell Mentor device
5
Description
Marginal bone loss
Timepoint
5 months after surgery
Method of measurement
Periapical radiography
Intervention groups
1
Description
Control group:
Osteotomy site is prepared using conventional drilling
Category
Treatment - Surgery
2
Description
Intervention group:
Implant osteotomy site is prepared using piezosurgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Ehsan Hooshyar
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Faculty of dentistry, Hamedan University of Medical Sciences
Full name of responsible person
Shahin Kasraei
Street address
Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Faculty of dentistry, Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ehsan Hooshyar
Position
Assistant
Other areas of specialty/work
Street address
Department of Periodontology, Faculty of Dentistry, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3824 7464
Fax
Email
skafilzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ehsan Hooshyar
Position
Assistant
Other areas of specialty/work
Street address
Department of Periodontology, Faculty of Dentistry, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3824 7464
Fax
Email
sn4014@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ehsan Hooshyar
Position
Resident of Periodontics
Other areas of specialty/work
Street address
Department of Periodontology, Faculty of Dentistry, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3824 7464
Fax
Email
sn4014@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)