Determining clinical indices comparing two types of sulcular incision and papilla sparing incision for implant placement
Design
Clinical trial with a control group, with parallel groups, triple-blind, randomized, phase 3 on 46 patients, for randomization, sealed envelope method and random number table are used.
Settings and conduct
Place: Faculty of Dentistry, Tehran University of Medical Sciences, intervention: papilla sparing incision, control: sulcular incision, blinding: triple-blind (researcher, statistical analyzer and participants)
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1- Patients over 18 years of age who refer to the periodontics department of Tehran Faculty of Dentistry need implant placement in the edentulous area in the anterior or posterior region in a delayed or late implantation.
2- The presence of teeth on the mesial or distal side or both sides of the edentulous area
3- Non-smokers or people who consume less than 10 cigarettes per day
4- Having informed consent
Exclusion Criteria:
1- Pregnancy and lactation and suffering from diabetes
2- The need for an implant in the second molar area towards the back
3- The tooth adjacent to the edentulous area has a clinical attachment loss of more than 2 mm
4- The need for simultaneous soft and hard tissue reconstruction and flap advancement at the time of implant placement
5- Implant adjacent to the free end edentulous area
6- Patient's lack of consent to continue cooperation in the research plan
Intervention groups
Intervention: In this group, a papilla sparing incision is made in the desired area for implant placement. Control: In this group, a sulcular incision is made in the desired area for the implant.
Main outcome variables
Changes in the height and volume of the papilla adjacent to the edentulous area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231115060069N1
Registration date:2023-11-19, 1402/08/28
Registration timing:prospective
Last update:2023-11-19, 1402/08/28
Update count:0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
Mahsa Etemadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4500
Email address
m-etemadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-24, 1403/01/05
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of sulcular incision versus papilla sparing incision on the tooth-implant papilla dimensions, a randomized clinical study
Public title
Evaluation of the effect of two incision techniques on the soft tissue dimensions around the implant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aging over 18 years who refer to the periodontics department of Tehran Faculty of Dentistry need implant placement in the edentulous area in anterior or posterior region in a delayed or late implantation.
The presence of teeth on the mesial or distal side or both sides of the edentulous area
patients without systemic conditions interfering with surgery (ASA 1 or 2)
Non-smokers or less than 10 cigarettes per day
presence of periodontal health (less than 4 areas with probe depth greater than 4 mm)
Fullmouth bleeding score and fullmouth plaque score less than 25%
Having informed consent
Exclusion criteria:
Pregnancy and lactation
Having diabetes
The need for an implant in the posterior second molar region
The tooth adjacent to the edentulous area have a clinical attachment loss of more than 2 mm
The need for simultaneous soft and hard tissue reconstruction and flap advancement at the time of implant placement
The implant adjacent to the free end edentulous area
The patient's lack of consent to continue cooperation in the research project
Severe side effects during treatment
The impossibility of placing the healing abutment on the day of surgery
Improper position of the implant
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual randomization; People who meet the entry criteria are assigned a number and enter the study. Then the patients are randomly divided into 2 intervention and control groups by the table of random numbers. For allocation concealment, the coded sealed envelope method with the random sequence will be used. The name of the surgical method is written inside a sealed envelope, then on the day of the surgery, one of the envelopes is opened and the surgery is performed based on that.
Blinding (investigator's opinion)
Triple blinded
Blinding description
patients participating in the study knowing that they are participating in a research study, are blinded to the allocation to the desired treatment group, the researcher and the statistical analyst are blinded to the type of surgical technique performed in each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
North Karegar St, Faculty of Dentistry, Tehran University of Medical Sciences, Tehran-Iran
City
Tehran
Province
Tehran
Postal code
Approval date
2023-11-15, 1402/08/24
Ethics committee reference number
R.TUMS.DENTISTRY.REC.1402.080
Health conditions studied
1
Description of health condition studied
Incision technique in implant insertion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in the height of the papilla adjacent to the edentulous area
Timepoint
Baseline, 3 months after surgery
Method of measurement
image j software
2
Description
Changes in the volume of the papilla adjacent to the edentulous area
Timepoint
Baseline, 3 months after surgery
Method of measurement
image j software
Secondary outcomes
1
Description
The presence of scar tissue
Timepoint
3 months after surgery
Method of measurement
mucoal scarring index
2
Description
Implant position
Timepoint
Immediately after implant placement
Method of measurement
Parallel periapical radiograph
3
Description
The amount of gingival recession
Timepoint
At baseline, 3 months after surgery
Method of measurement
Michigan probe with Williams numbering as the difference in the distance of the gingival margin from the mucogingival line
4
Description
Probing depth
Timepoint
The baseline, 3 months after surgery
Method of measurement
Michigan probe with Williams numbering in buccal, lingual, mesial and distal points of adjacent teeth
Intervention groups
1
Description
Intervention group: papilla sparing incision
Category
Treatment - Surgery
2
Description
Control group: sulcular incision
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Mahsa Etemadi
Street address
North Karegar St, Faculty of Dentistry, Tehran University of Medical Sciences, Tehran-Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 913 401 1266
Email
m-etemadi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Etemadi
Street address
North Kargar St, Faculty of Dentistry Tehran University of Medical Sciences, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4500
Email
m-etemadi@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Etemadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bostan Vesal dormitory, No.52, Bastani Parizi Alley, Vesal Shirazi St
City
Tehran
Province
Tehran
Postal code
1417743855
Phone
+98 913 401 1266
Email
mahsaemdi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Etemadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bostan Vesal dormitory, No.52, Bastani Parizi Alley, Vesal Shirazi St
City
Tehran
Province
Tehran
Postal code
1417743855
Phone
+98 913 401 1266
Email
mahsaemdi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Etemadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bostan Vesal dormitory, No.52, Bastani Parizi Alley, Vesal Shirazi St
City
Tehran
Province
Tehran
Postal code
1417743855
Phone
+98 913 401 1266
Email
mahsaemdi@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available