Comparative evaluation of periodontal Indices in the newly extracted alveolar cavity technique and delayed implants in patients who were candidate for implant surgery
Comparative evaluation of periodontal indices in immediate and delayed implants
Design
In this study, 98 patients were selected in interventional groups of immediate and delayed implants. All patients indicated implant placement in the above methods. Finally, periodontal indices were evaluated in a comparative way.
Settings and conduct
This study was performed following two techniques: 1) Immediate technique: The tooth was a-traumatically extracted and washed into saline solution and curettage. The drilling was done in the right position and the area that implant was inserted. If the torque was above N / CM 35 and had a good initial stability, after 24 hours after the surgery, the interim crown was referred to the prosthetic and placed after 4 to 3 months of permanent crown surgery. At this stage, the papillary index, the bleeding index, and the probing pocket depths were measured, and the PA radiography was used to evaluate the radiolucency and also to determine the rate of bone resorption. The patient then returned 8 months to re-measure the indicators.
2) Delayed technique: In this technique, toothless cases that were candidates for the implant were selected and after anesthetizing and incision, mucousal flap was performed and exposed bone and implants were implanted. After 3 months, the patient was referred and the crown was placed. In this stage, the above indicators were measured and also were measured 8 months later.
Participants/Inclusion and exclusion criteria
Age over 25 years old, Plaque index of 20%, Having no active infection at the site of implantation
Intervention groups
First intervention group: Implant loading by immediate method (implantation immediately after tooth extraction).
Second intervention group: Delayed implant loading (common method
Main outcome variables
Success rate and treatment stability
Bone resorption
radiolucency
Gingival bleeding
Pocket depth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181128041779N1
Registration date:2019-01-02, 1397/10/12
Registration timing:retrospective
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Fateme Yoonesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5697 1653
Email address
fateme_yoonesi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
2018-10-23, 1397/08/01
Scientific title
Comparative evaluation of periodontal Indices in the newly extracted alveolar cavity technique and delayed implants in patients who were candidate for implant surgery
Public title
Comparison of immediate and delayed implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 25 years old
Having plaque index of 20%
Not having an active infection at the implant site
Exclusion criteria:
Having systemic diseases that prevent osseointegration
Having physical or mental disability or para-function
Being a smoker
Having Bruxism
Having Clenching
Age
From 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Actual sample size reached:
98
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad dental school, Vakilabad boulevard.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.mums.sd.REC.1394.287
Health conditions studied
1
Description of health condition studied
Immediate implants and delayed implants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The success rate and stability of the treatment, bone resorption, having or not having radiolucency, amount of gingival bleeding, depth of pocket
Timepoint
3-4 months after surgery, 8 months after the first examination
Method of measurement
By using papilla index, bleeding index, probing pocket depths
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Immediate technique: The tooth was a-traumatically extracted and washed into saline solution and curettage. The drilling was done in the right position and the area that implant was inserted. If the torque was above N / CM 35 and had a good initial stability, after 24 hours after the surgery, the interim crown was referred to the prosthetic and placed after 4 to 3 months of permanent crown surgery. At this stage, the papillary index, the bleeding index, and the probing pocket depths were measured, and the PA radiography was used to evaluate the radiolucency and also to determine the rate of bone resorption. The patient then returned 8 months to re-measure the indicators.
Category
Treatment - Surgery
2
Description
Intervention group: Delayed technique: In this technique, toothless cases that were candidates for the implant were selected and after anesthetizing and incision, mucousal flap was performed and exposed bone and implants were implanted. After 3 months, the patient was referred and the crown was placed. In this stage, the above indicators were measured and also were measured 8 months later.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad dental school
Full name of responsible person
Dr. Naser Sargolzaei
Street address
Mashhad dental school, Vakilabad boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mail@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Naser Sargolzaei
Street address
Mashhad dental school, Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mail@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Research Deputy of Mashhad Dental School
Full name of responsible person
Dr. Hossein Bagheri
Street address
Mashhad dental school, Vakilabad boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mail@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Mashhad Dental School
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Naser Sargolzaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad dental school, Vakilabad boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
Sargolzaien@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Arab
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad dental school, Vakilabad boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
Arabhr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Younesi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Mashhad dental school, Vakilabad boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
Younesif941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available