Maxillary Sinus Lifting: A Comparison Of Success Rate of Direct Versus Indirect Sinus Lifting for Vertical Bone Augmentation in Patients Receiving Dental Implants
To compare the direct and indirect sinus lifting techniques for maxillary bone augmentation in patients receiving Implants
Design
Single Blinded Randomized Controlled Trial
Settings and conduct
Trail will be performed in Oral and Maxillofacial Surgery Department of AFID. Two groups will be made by simple randomization of patients getting sinus lifting done for placement of Dental implants in the Maxillary Molar region . One group will get the sinus lifting done via Direct method and second group will get it done by Indirect method.Patients will be randomized by using lottery method and concealed lottery tickets will be used for the purpose of blinding.
Participants/Inclusion and exclusion criteria
INCLUSION
Having physical status 1 according to ASA classification
Bone Height Less than 5mm in Maxillary Molar Region
EXCLUSION
Pregnant women, nursing mothers, smokers
Patient with infection in Maxillary Molar Region
Patients Having Sinus Pathology
Patient with medications that can alter pain perception.
Intervention groups
Direct Sinus Lifting will be performed in one group and indirect in Other for Augmentation of Vertical Bone Height
Main outcome variables
Post Op Pain;
Post Op Swelling;
Gingival Swelling;
Implant Stability;
Patient's Compliance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230926059527N2
Registration date:2023-09-30, 1402/07/08
Registration timing:registered_while_recruiting
Last update:2023-09-30, 1402/07/08
Update count:0
Registration date
2023-09-30, 1402/07/08
Registrant information
Name
AMMAR Yasir
Name of organization / entity
Armed Forces Institute of Dentistry
Country
Pakistan
Phone
+92 346 7330822
Email address
seirraalphayankee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-27, 1402/07/05
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Maxillary Sinus Lifting: A Comparison Of Success Rate of Direct Versus Indirect Sinus Lifting for Vertical Bone Augmentation in Patients Receiving Dental Implants
Public title
Maxillary Sinus Lifting: A Comparison Of Success Rate of Direct Versus Indirect Sinus Lifting for Vertical Bone Augmentation in Patients Receiving Dental Implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having physical status 1 according to ASA classification
HaviBone Height Less than 5mm in Maxillary Molar Region
Exclusion criteria:
Pregnant women, nursing mothers & smokers
Patient with infection in Maxillary Molar Region
Patients Having Sinus Pathology
Patient with medications that can alter pain perception
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was performed by using lottery method(Lottery chits with even and odd numbers were used. Patients with even number chits were placed in one group and with odd number chits in the second group).Allocation concealment was done using folded chits. Patients in first group got sinus lifting done by Direct Method and in second group Indirect Sinus lifting was performed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were blinded as they were not informed about the treatment modality used for management of their ailment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of AFID
Street address
AFID CMH Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2021-07-19, 1400/04/28
Ethics committee reference number
918/Trg Dated 13 May 2020
Health conditions studied
1
Description of health condition studied
Missing tooth
ICD-10 code
K08.1
ICD-10 code description
Complete loss of teeth
Primary outcomes
1
Description
Post Op Pain
Timepoint
3rd and 5th Day after Intervention
Method of measurement
Visual Analogue Scale
2
Description
Gingival inflammation
Timepoint
3rd and 5th Day after Intervention
Method of measurement
Gingival Index
3
Description
Swelling
Timepoint
3rd and 5th Day after Intervention
Method of measurement
Observed Clinically
4
Description
Implant Stability
Timepoint
03 Months after Intervention
Method of measurement
Glickemans method
5
Description
Per Op patient Compliance
Timepoint
immediately after intervention
Method of measurement
Licekrts Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Direct Sinus Lifting will performed to achieve adequate bone height for placement of dental implant in the maxillary molar region. After Caldwellluc incision the bony window will be created. After lifting the sinus membrane the bone graft will be placed in the desired area. Closure will be performed using Vicryl sutures
Category
Treatment - Surgery
2
Description
Intervention group 2: Indirect Sinus Lifting will performed to achieve adequate bone height for placement of dental implant in the maxillary molar region. After extraction of the tooth the same socket will be used to lift the sinus membrane the bone graft will be placed in the desired area. Closure will be performed using Vicryl sutures
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
AFID
Full name of responsible person
Syed Ammar Yasir
Street address
AFID, CMH Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 346 7330822
Email
seirraalphayankee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AFID
Full name of responsible person
Syed Ammar Yasir
Street address
AFID, CMH rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 314 5254504
Email
seirraalphayankee@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AFID
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
Armed Forces Institute of Dentistry
Full name of responsible person
Ammar Yasir
Position
Specialty Resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
AFID, CMH Rawalpindi Near Lalkurti
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 346 7330822
Fax
Email
seirraalphayankee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Armed Forces Institute of Dentistry
Full name of responsible person
Ammar Yasir
Position
Specialty Resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
AFID, CMH Rawalpindi Near Lalkurti
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 346 7330822
Fax
Email
seirraalphayankee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Armed Forces Institute of Dentistry
Full name of responsible person
Ammar Yasir
Position
Specialty Resident
Latest degree
Medical doctor
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
AFID, CMH Rawalpindi Near Lalkurti
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 346 7330822
Fax
Email
seirraalphayankee@gmail.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study Protocol, Statistical Analysis Plan, Informed Consent Clinical Study Reports will be shared
When the data will become available and for how long
After Publication Of Study
To whom data/document is available
Medical Related Individuals
Under which criteria data/document could be used
Data Can be Used by Medical related Personal for the patients going to have dental Implants in maxillary Molar Region
From where data/document is obtainable
Phone
Whatsapp
What processes are involved for a request to access data/document