Comparison of Collacone and BoneProtect Cone, in socket preservation.
Design
A controlled, parallel-group, triple-blind, randomized clinical trial on 45 patients. Excel software was used for randomization.
Settings and conduct
The study is carried out in Baghban Sari dental clinic.
First, the patient's medical history is completed. Patients receive 2 grams of amoxicillin and one ibuprofen one hour before surgery. The patient reads and signs the informed consent form. The tooth will be examined. Infiltrated local anesthesia will be injected in the buccal and palatal area with a short needle. Tooth extraction surgery is performed in an atraumatic manner and the tooth socket is freshly extracted and washed with saline. After tooth extraction, the buccal-palatal distance of the alveolar and the height of the ridge are measured by CBCT imaging. According to the grouping, the desired intervention will be done and the tooth will be sutured. After 90 days, re-measurement of the greatest buccopalatal distance and ridge height is performed with CBCT imaging. The data will then be sent for analysis.
The study is triple blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: extraction of maxillary anterior tooth or premolar; 18 to 45 years old and healthy; good oral health; no lesion and pain; intact socket wall; patient satisfaction
Exclusion criteria: smoking patients; pregnant; history of allergy to certain substances; use of certain drugs; history of radiotherapy or chemotherapy
Intervention groups
Control Group: No restorative material is placed in the tooth socket.
Test Group 1 (CC): Collacone will be placed in the dental socket.
Test Group 2 (BPC): BoneProtect Cone will be placed in the dental socket.
Main outcome variables
buccopalatal width of alveolar ridge; bone height; bone trabeculation; Keratinized tissue width; gum thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231105059969N1
Registration date:2024-05-28, 1403/03/08
Registration timing:prospective
Last update:2024-05-28, 1403/03/08
Update count:0
Registration date
2024-05-28, 1403/03/08
Registrant information
Name
Hossein Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3335 4097
Email address
yousefihossein1999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Collacone and BoneProtect Cone in socket preservation: A triple-blind randomized clinical trial
Public title
Comparing the effect of Collacone and BoneProtect Cone in bone resorption
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient needs to extract a Maxillary anterior or premolar tooth.
Patient must be between the ages of 18 and 45 without reported systemic disease and be in good general health and in the ASA I or ASA II group in terms of surgical risk.
Patient should be in good oral health and without periodontal disease.
Patient should not show any signs of lesion, acute inflammation and acute pain.
The walls of the socket after tooth extraction should be intact and without noticeable fractures of the bone plates. All teeth must be atraumatically extracted with periotome, fine elevator and root forceps.
Patient has accepted the conditions of the study after reading and signing the consent form.
Exclusion criteria:
Smokers
Pregnant women
Patients with a history of allergy to certain drugs or substances
Patients who use drugs that interfere with bone healing process, such as bisphosphonates
Patients with a history of radiotherapy or chemotherapy
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method will be used to allocate the samples to intervention and control groups. Blocks will be considered as 3 blocks.
All eligible people will be randomly assigned to three groups (A-C) using block classification. To do this through Excel software, the samples will be placed in 15 blocks of 3 (the total sample size is 45). Blocks of 3 will be ABC, BCA, BAC, ACB, CAB and CBA.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is triple blind. The trained student, analyst, patient, and oral and maxillofacial radiology specialist will not know the type of restorative material that will be placed in a dental socket. The restorative material will be opened by a sterile assistant and placed in a fresh dental socket by the operator. Both Collacone and BoneProtect Cone are similar in appearance and physical properties and it is not possible to distinguish them from each other.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences headquarters, the beginning of Valiasr Highway, Imam Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2023-10-14, 1402/07/22
Ethics committee reference number
IR.MAZUMS.REC.1402.393
Health conditions studied
1
Description of health condition studied
socket preservation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Buccopalatal width of the alveolar ridge
Timepoint
Immediately after surgery and 90 days after surgery
Method of measurement
Cone-beam computed tomography (CBCT) radiology
2
Description
Height of bone
Timepoint
Immediately after surgery and 90 days after surgery
Method of measurement
Cone-beam computed tomography (CBCT) radiology
Secondary outcomes
1
Description
Keratinized tissue width
Timepoint
Immediately after surgery and 90 days after surgery
Method of measurement
Periodontal probe
2
Description
Gum thickness
Timepoint
Immediately after surgery and 90 days after surgery
Method of measurement
Digital caliper and endodontic spreader
3
Description
Bone trabeculation
Timepoint
Immediately after surgery and 90 days after surgery
Method of measurement
cone-beam computed tomography radiology
Intervention groups
1
Description
Control group:First, a medical history is taken from the patient and an oral examination is performed. Then, the conditions and purpose of the study will be explained to the patient, and if he is satisfied, the patient will fill and sign the informed consent form after reading. All patients participating in the study will receive 2 grams of amoxicillin for preventive treatment and one ibuprofen one hour before the operation. Infiltrated local anesthesia will be injected in the buccal and palatal areas of the desired tooth. The anesthetic is lidocaine 2% with epinephrine 1:80000 and a maximum of two carpools of anesthetic will be injected to prevent poisoning. Then, a finger endodontic spreader (Thomas) with a silicone stopper is inserted to measure the thickness of the gum perpendicular to the mucosa with light force in the midbuccal area of the tooth socket until it reaches the bone and its stop is set on the gum. Then the gingival thickness is measured with a digital caliper (RoHS) by a trained student. The edges of the caliper are placed on the tip of the spreader and the stop, and the size shown on the display of the caliper will be recorded. The width of the keratinized gingiva will also be measured with a periodontal probe by a trained student. A student performing clinical measurements of gingival thickness and width of keratinized gingiva was trained prior to the design. Before starting the work, 5 patients who needed extraction of maxillary anterior teeth and premolars were selected out of the research plan. Gingival thickness and keratinized gingival width were measured. Repeated measurements were performed with an interval of 7 days from the first and second time. Intraclass correlation coefficients (Pearson's correlation coefficient) as a measure of inter-examiner repeatability for gingival thickness and keratinized gingival width were 0.85 and 0.82, respectively. Tooth extraction will be performed by an oral and maxillofacial surgery specialist in an atraumatic manner, preserving as much of the alveolar bone as possible. First, the tooth will be declawed and loosened by the periotome and elevator, then it will be removed from the dental socket by forceps or root puller. After the extraction of the tooth, the fresh tooth socket is gently cut and washed with saline in order to keep the bone walls intact. Then the tooth socket is sutured with 4-0 Vicryl absorbable suture in the form of a figure of 8 (cross). became. Post-operative care will be explained to the patient and a prescription will be prescribed if needed. At this stage, the patient is referred for CBCT imaging (Kodak (Carestream CS 9300)) to measure the buccopalatal width of the alveolar appendage and the height of the alveolar ridge. In measuring the height, in the central, lateral and canine areas, the minimum distance from the crest to the floor of the nose, in the premolars, the minimum distance from the crest to the floor of the sinus (24, 25) on cross-sectional sections with a thickness of 0.5 mm and a distance of 2 mm will be measured. field of view is 5 x 5 cm high resolution, with 90 kVp and 6.3 mA and 20 s and voxel size is 90 microns. Photographs are taken with CS imaging software and measured with OnDemand software. The DICOM file of the images will be used for fractal analysis. Photographing and interpretation will be done by two oral and maxillofacial radiologists. The patient will return for follow-up in 30 and 60 days after surgery to check the state of bone repair. Follow-ups will be done by an oral and maxillofacial surgeon. On the 90th day after surgery, the patient will be called for a final examination, and re-measurement of the buccopalatal distance and ridge height will be performed with CBCT, and fractal analysis will be performed from the DICOM file. Gingival thickness and keratinized gingival width will also be measured. The data will then be sent for analysis.
Category
N/A
2
Description
Intervention group 1: After extracting the tooth and washing it with saline, a Collacone (Botiss Biomaterial, Germany) collagen cone will be placed in the socket. The restorative material will be opened by the sterile assistant, without the knowledge of the trained student and the patient, and will be placed in a fresh container by the operator himself. The restorative materials used are similar in appearance. Then, the tooth socket will be sutured with a 4-0 vicryl absorbable suture in the form of a figure of 8 (cross). Other steps are similar to the control group.
Category
Treatment - Drugs
3
Description
Intervention group: After extracting the tooth and washing it with saline, a BoneProtect Cone (Dentegris, Germany) collagen cone will be placed in the socket. The restorative material will be opened by the sterile assistant, without the knowledge of the trained student and the patient, and will be placed in a fresh container by the operator himself. The restorative materials used are similar in appearance. Then, the tooth socket will be sutured with a 4-0 vicryl absorbable suture in the form of a figure of 8 (cross). Other steps are similar to the control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghban Dental Clinic
Full name of responsible person
Amir Hossein Moadabi
Street address
Baghban dental clinic, Kazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4819895475
Phone
+98 11 3324 4894
Email
a.moaddabi2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Research and Technology Vice-Chancellor, 3rd Floor, Building No. 2, Mazandaran University of Medical Sciences and Health Care Services, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Amir Hossein Moaddabi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Baghban Dental Clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4819895475
Phone
+98 11 3324 4894
Email
a.moaddabi2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amir Hossein Moaddabi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Baghban Dental Clinic, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4819895475
Phone
+98 11 3324 4894
Email
a.moaddabi2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hossein Yousefi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 23, Felestin 6., Felestin Ave., Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4815665741
Phone
+98 11 3335 4097
Fax
Email
yousefihossein1999@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the completion of the study and the publication of the article resulting from it, the documentation related to the main and secondary outcomes will be available upon request from the research author, after de-identifying the individuals.
When the data will become available and for how long
The start of the access period, 6 months after the publication of the article resulting from the project.
To whom data/document is available
All people
Under which criteria data/document could be used
The mentioned documents, if used for similar studies, will be available after the request from the responsible researcher.
From where data/document is obtainable
Responsible researcher: Dr. Amirhossein Moaddabi, address: Khazar Blvd., Mazandaran, Sari, Baghban Dental Clinic, contact number: 09127103916 and email: a.moaddabi2@gmail.com
What processes are involved for a request to access data/document
It can be received from the responsible researcher through a personal visit, phone call or e-mail.