Dimensional changes of alveolar socket following the tooth extraction with or without Using absorbable and hemostatic collagen
Design
Not-blinded non-randomized clinical trial with control group
Settings and conduct
Atraumatic tooth extraction was performed in Ahvaz dentistry faculty for all
patients under local anesthesia. The post-extraction sockets
were debrided.42 patients were assigned to one of two
groups for post-extraction socket preservation:
Group A consisted of 21 patients in
whom collagenic cones were placed into the extraction
sockets.
Group B consisted of 21
patients in whom collagenic cones were not placed into the extraction
sockets.
The patients were examined by the surgeon who performed the
surgical procedure at day 7 and then at 3 months after surgery.The reduction of alveolar bone, measured at the cervical
part of the socket, was determined before socket preservation
and 3 months later using a periodontal probe and
caliper in the following ways:
1. Distance between a line which connects the cementoenamel
junctions of the mesial and distal tooth, and
crestal bone at the central point of the buccal and
palatal sites (vertical dimension)
2. Distance between the central point of the buccal and
palatal walls (horizontal dimension) at the level of
crestal bone and 3 and 5 millimeter below CEJ
Participants/Inclusion and exclusion criteria
patients with indications for tooth extraction such as fracture of the tooth, non-vital tooth without the possibility of endodontic treatment and restoration, chronic periodontitis,in the maxilla or mandible premolar tooth aria with good oral hygiene
Intervention groups
Intervention group: after tooth extraction absorbable collagen sponge is used for socket preservation
control group:after tooth extraction absorbable collagen sponge is not used for socket preservation
Main outcome variables
width and height of alveolar ridge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190728044361N1
Registration date:2020-02-25, 1398/12/06
Registration timing:retrospective
Last update:2020-02-25, 1398/12/06
Update count:0
Registration date
2020-02-25, 1398/12/06
Registrant information
Name
Mohammadreza Badri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5234 2927
Email address
badri.mr@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dimensional changes of alveolar socket following the tooth extraction with or without Using absorbable and hemostatic collagen
Public title
Dimensional changes of alveolar socket following the tooth extraction with or without Using absorbable and hemostatic collagen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with indications for tooth extraction such as fracture of the tooth, non-vital tooth without the possibility of endodontic treatment and restoration, chronic periodontitis, with good oral hygiene
patients with indications for tooth extraction such asnon-vital tooth without the possibility of endodontic treatmentand restoration
patients with indications for tooth extraction such aschronic periodontitis
with good oral hygiene
in maxillary or mandibular premolar aria
Exclusion criteria:
smokers patients
history of uncontrolled systemic disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Not randomized
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
Ethics committee of Ahvaz Jundishapur University of Medical Science
Street address
Golestan street
City
ahvaz
Province
Khouzestan
Postal code
6135715775
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.AJUMS.REC.1398.311
Health conditions studied
1
Description of health condition studied
alveolar bone healing after extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Width of alveolar ridge
Timepoint
before extraction,after 1 week ,after 3 mounth
Method of measurement
using periodontal probes and ridge mapping caliper
2
Description
height of alveolar ridge
Timepoint
before extraction,after 1 week ,after 3 mounth
Method of measurement
using periodontal probes and ridge mapping caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after tooth extraction absorbable collagen sponge is used for socket preservation
Category
Treatment - Drugs
2
Description
Control group: without using absorbable collagen sponge after tooth extraction
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundi Shapur University Of Medical Sciences School Of Dental Medicine
Full name of responsible person
Dr Navid Dorestan
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5169
Email
Navid.dorestan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badavi
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3336 7543
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Navid Dorestan
Position
Asistant Professor Of Periodontology
Latest degree
Specialist
Other areas of specialty/work
periodontist
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3391 1313
Email
Navid.dorestan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Navid Dorestan
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3391 1313
Email
Navid.dorestan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
دکتر نوید درستان
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Jundi Shapur University Of Medical Sciences, Golestan street
City
ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3391 1313
Email
Navid.dorestan@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