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Evaluation of clinical and radiographic conditions of implants placed with closed sinus lift technique with and without bone graft

Protocol summary

Study aim
Evaluation of clinical and radiographic conditions of implants placed with closed sinus lift technique with and without bone graft
Design
Clinical trial with control group, double-blind, randomized, on 40 patients. A random number table was used for randomization using closed envelopes
Settings and conduct
A total of 40 patients in need of implants in the posterior maxilla region with a minimum bone height of 5 mm referred to prosthodontics and implant dentistry, Mashhad Dental School, are selected for the study. Patients are randomly sorted into two groups of closed sinus lifts with and without bone graft materials by a random number table. The closed sinus lift surgical procedure for both groups is as follows: before the implant is placed, the Sinus lift is closed. Then, in one group, the bone graft material is used simultaneously as elevating the sinus lift. In the other group, this procedure is performed without the graft material, and then the implant is placed. Dental CBCT images are taken before surgery and six months after surgery. In addition, PA radiographic images are also taken before surgery, instantly after surgery, 3and 6 months later. Bone height is measured and evaluated at different distances with those images.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients over 18 years of age 2.The missing tooth in the posterior maxillary area 3. At least 5 mm bone height exclusion criteria: 1.Having a Medical contraindication for implant surgery 2.Rupture of the sinus membrane during surgery 3.Implant loss
Intervention groups
In the intervention group, the bone graft is placed concurrently with elevating the sinus in a closed method to increase the thickness and height of the bone, and then an implant is placed.
Main outcome variables
vertical bone gain, pain, swelling

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140817018834N9
Registration date: 2021-06-12, 1400/03/22
Registration timing: prospective

Last update: 2021-06-12, 1400/03/22
Update count: 0
Registration date
2021-06-12, 1400/03/22
Registrant information
Name
Nahid Nasrabadi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences of Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1621 2623
Email address
nasran@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-15, 1400/03/25
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical and radiographic conditions of implants placed with closed sinus lift technique with and without bone graft
Public title
closed sinus lift with and without bone graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients over 18 years of age 2. A missing tooth in in the posterior maxilla 3. At least 5 mm bone height 4. The patient in need of an implant unit
Exclusion criteria:
Medical contraindication for implant surgery Perforation of the sinus membrane during surgery Failure of implant
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be simple and the Randomization unit will be individual. Randomization take place using www.randomization.com website and random numbers will be inserted in sealed envelopes. on the basis of the number in the envelope (even and odd), the patient will be allocated to the test or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
As to the study design of the possibility of blinding the participants, there is no principal investigator or clinic staff, and Each person's files and data are made available to the data analyzer and the Outcome assessor without knowing the case group or being in control.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences_Mashhad faculty of dentistry
Street address
Vakil abad blvd, Mashhad Dental Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.132

Health conditions studied

1

Description of health condition studied
The patient needs implant placement followed by a closed sinus lift.
ICD-10 code
K08.24
ICD-10 code description
Minimal atrophy of maxilla

Primary outcomes

1

Description
Bone height at the time of implant placement and 3 and 6 months after surgery
Timepoint
Bone height at the time of implant placement and 3 and 6 months after surgery
Method of measurement
The use of PA and CBCT radiographs

Secondary outcomes

1

Description
Pain and swelling after surgery
Timepoint
1-3-10 days after surgery
Method of measurement
The patient is asked about the amount of pain by telephone using the VAS index on the first, third, and tenth days, and the patient is asked to rate their pain on a scale from 0 to 10 and is also asked about the presence or absence of edema. In addition, due to special conditions in COVID-19 prevalence and attracting patient involvement and cooperation, On the third day, the patient will be examined remotely by sending a full face photo.

Intervention groups

1

Description
Intervention group: Bone graft placement is performed concurrently with sinus elevation in a closed method to increase bone thickness and height.
Category
Treatment - Surgery

2

Description
Control group: elevating the sinus lift alone and the simultaneous placement of the implant.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Dental Facult
Full name of responsible person
Nahid Nasrabadi
Street address
Vakilabad blvd- Mashhad Dental Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7114
Email
nasran@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mofsen Tafaghodi
Street address
Daneshgah Street, next to Hoveyzeh Cinema, Ghorashi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
tafaghodim@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
100
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
Nahid Nasrabadi
Position
assistant Professor Of Periodantics/Mashhad Dental Faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil abad blvd-Mashhad Dental Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7114
Email
nasran@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Nasrabadi
Position
Assistant Professor Of Periodantics/Mashhad Dental Faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad Blvd- Mashhad Dental Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7114
Email
nasran@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Nasrabadi
Position
Assistant Professor Of Periodontology/Mashhad Dental Faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad Blvd-Mashhad Dental Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
098 51 38067114
Email
nasran@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there in no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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