determination of alloderm and Connective Tissue Graft (CTG) on vertical soft tissue thickness on two-stage implant insertion
Design
Randomized two-arm parallel, double-blind trial, sample size 20 (10 patients in each group)
Settings and conduct
In this study, 1 hour before surgery, the patient receives 1 gram of prophylactic dose of amoxicillin, the procedure is then continued at 500 mg 3 times a day for 1 week after the intervention .The entire surgical procedure is performed by a surgeon. Buccal flap elevates with full thickness flap and vertical soft tissue dimension measured. Perio probe insert on alveolar ridge on implant insertion site. If vertical dimension of soft tissue was more than 3mm the patient went out of the study. After implant insertion in first group connective tissue graft
(CTG) placed and in the second group ADM was placed in 10*10 mm dimension on alveolar ridge due to randomization. Flap sutured with 0/4 silk suture. And after 3 month recalling the patient happened and on healing abutment placement measurement of soft tissue thickness evaluated and reported by the blinded examiner who was not aware of belonging of patient to each groups.
Participants/Inclusion and exclusion criteria
1-patients candidate for implant treatment
2-thin crestal mucosal tissue (2 mm or less); partial edentulousness in different areas of the mouth
3-no bone augmentation process before and during implant placement.
Intervention groups
CTG and alloderm insertion on a two-stage implant for evaluation of these materials on progresstion and improvement of soft tissue around dental implants
Main outcome variables
soft tissue thickness around implant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211003052658N1
Registration date:2021-11-07, 1400/08/16
Registration timing:retrospective
Last update:2021-11-07, 1400/08/16
Update count:0
Registration date
2021-11-07, 1400/08/16
Registrant information
Name
amin mohammadpourkolde
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4212 5497
Email address
aminmpkld71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-23, 1400/03/02
Expected recruitment end date
2021-08-29, 1400/06/07
Actual recruitment start date
2021-07-24, 1400/05/02
Actual recruitment end date
2021-10-19, 1400/07/27
Trial completion date
2021-10-23, 1400/08/01
Scientific title
Comparison between acellular dermal matrix and connective tissue graft on vertical soft tissue thickness during submerged implant insertion
Public title
Comparison between acellular dermal matrix and connective tissue graft on vertical soft tissue thickness during submerged implant insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Thin crestal mucosal tissue (2 mm or less)
Partial edentulousness in different areas of the mouth
No bone agmentation process before and during implant placement
Exclusion criteria:
Patients undergoing soft and hard tissue regeneration treatments
Implant loss in the area
Patients under 18 years of age
Has a medical contraindication for implants
Has a history of periodontitis, has a history of uncontrolled diabetes and smoking and alcohol consumption
Systemic disease that interferes with implant placement, history of radiation therapy and chemotherapy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who have been included in the study based on inclusion and exclusion criteria, randomly allocate into control and test group through randomized block method. Each block will contain 2,4 or 8 patient. After completion of each block treatment will be done by a randomized permutation on patient. Blocks and permutations on each block will create by agricolae package in R software with a definite seed. The number of the seed provide the possibility of recreation of random sequence. regard to this package number of block, size of block, sequence in each block and type of each patient treatment will present as outcome of the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients included in the study did not know that they belonged to the control and intervention groups. And measurements are made by another person during the first and second stages who does not know that the treated people belong to the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qavin Shahid bahonar bolvar .Qazvin univercity of medical science
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2021-07-20, 1400/04/29
Ethics committee reference number
ir.qums.rec.1400.187
Health conditions studied
1
Description of health condition studied
mucosal thinness in relation to peri-imlant disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
soft tissue thickness
Timepoint
on implant insertion and on healing abutment placement
Method of measurement
with periodontal probe and gage guide
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: CTG placement
Category
Treatment - Other
2
Description
Intervention group 2: ADM placement
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin university of medical science
Full name of responsible person
Amin Mohammadpour Kolde
Street address
Bahonar Bolvar
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
internationalaffairs@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mehdi Mirhashemi
Street address
Bahonar Bolvar
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
internationalaffairs@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?