Evaluation of the amount of buccal bone plate regeneration using CBCT following immediate implant placement in dental sockets with buccal wall dehiscence by two surgical techniques: open flap and flapless along with GBR
Determining the amount of buccal bone plate reconstruction following immediate implant placement with buccal wall dehiscence with two surgical techniques, open flap and flapless along with GBR by CBCT
Design
The clinical trial has two parallel groups, single blind and a sample size of 24 patients. Randomization is done using the random number generation option of the kitset.ir site
Settings and conduct
Patients applying for immediate implant placement with buccal wall dehiscence referring to Babol Dental Faculty are randomly subjected to open flap and flapless surgery. The height and thickness of the buccal bone wall before surgery and 6 months later were measured by CBCT and the amount of reconstruction. The bone will be evaluated in each group. First group: method without flap, supra crestal fibers are cut before tooth extraction with a 15C surgical blade. After implant implantation, a collagen membrane is prepared according to the size of the pocket in the shape of an ice cream cone to reconstruct the plate, and a bone allograft is also used .Second group: open flap in this group, a crestal and two vertical incisions are made and the flap is raised in full thickness. the type of implant and the type of bone grafting will be the same as the first group.
Participants/Inclusion and exclusion criteria
The main entry conditions include people over 18 years of age with maxillary anterior teeth that have been affected by fractures or endodontic lesions that have led to dehiscence or the loss of the buccal bone plate ؛The conditions of non-entry include the presence of periodontal disease or gingivitis.
Intervention groups
The study has two groups with two different surgical techniques. In one group, the surgical technique is flapless, and in the other group, the surgical technique is open flap.
Main outcome variables
Buccal bone height; Buccal bone thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230117057150N1
Registration date:2023-01-24, 1401/11/04
Registration timing:prospective
Last update:2023-01-24, 1401/11/04
Update count:0
Registration date
2023-01-24, 1401/11/04
Registrant information
Name
Sima Sangchouli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
sima_sangchouli@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the amount of buccal bone plate regeneration using CBCT following immediate implant placement in dental sockets with buccal wall dehiscence by two surgical techniques: open flap and flapless along with GBR
Public title
the effect of flapless surgery on bone regeneration following immediate implant placement ؛ the effect of open flap surgery on bone regeneration following immediate implant placement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with hopeless anterior teeth of the maxilla with buccal wall dehiscence
Exclusion criteria:
The presence of periodontal disease in hopeless anterior teeth of the maxilla
People with medical and psychiatric problems for whom surgery is contraindicated
Smokers and alcoholism
pregnant women
People with bruxism or other parafunctional dental habits
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly divided into two groups: randomization will be done using the random number generation option of the kitset.ir website, so that the first half will be in the flapless group and the second half will be in the open flap group.
Blinding (investigator's opinion)
Single blinded
Blinding description
CBCT images are blindly analyzed by a radiologist in order to evaluate the regeneration of dental socket buccal bone plate 6 months after the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Babol University of Medical Sciences
Street address
ganj afrouz street
City
Babol
Province
Mazandaran
Postal code
4774547176
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.MUBABOL.REC.1401.157
Health conditions studied
1
Description of health condition studied
Dehiscence of buccal wall of dental socket
ICD-10 code
K08.9
ICD-10 code description
Disorders of teeth and supporting structures، unspecified
Primary outcomes
1
Description
Buccal bone height: dependent variable, quantitative continuous; The method of measurement is from the most coronal part of the remaining bone crest to the floor of the nasal cavity or maxillary sinus.
Timepoint
CBCT time before surgery and 6 months after surgery.
Method of measurement
Buccal bone height: The method of measurement in CBCT images is from the most coronal part of the remaining bone crest to the floor of the nasal cavity or maxillary sinus in millimeters.
2
Description
Buccal bone thickness: dependent variable, quantitative continuous; The method of measurement is from the apical millimeter of the crest of the buccal bone.
Timepoint
CBCT time before surgery and 6 months after surgery.
Method of measurement
The thickness of the buccal bone: the method of measurement is from the apical millimeter of the crest of the buccal bone in millimeters.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: flapless surgery technique, The surgical protocol will require atraumatic extraction of the tooth without a flap. Dental debridement and clinical examination will be performed to assess the lack of labial plate and ensure the presence of sufficient interproximal bone. Osteotomy is performed with a palatal inclination to place the implant. In this study, tapered implant (DIO) will be used. After planting the implant, a pocket remains relative to the buccal plate. A collagen membrane (cenoderm-kish-iran) is prepared in the shape of an ice cream cone to reconstruct the plate. The membrane is placed inside the remaining buccal bone plate, and the bone graft (FDBA) with a particle size of 500-1000 micrometers, 0.25-0.5 cc (CenoBone-Kish-Iran) is placed in the implant gap and buccal contour. After socket filling with Bone graft, the coronal part of the membrane is folded to cover the socket, and a horizontal mattress suture is placed on the palate to stabilize the membrane. CBCT images using a planmeca device (finland) are prepared before surgery (T0) and 6 months (T1) after recovery in order to evaluate the amount of buccal bone plate regeneration.
Category
Treatment - Surgery
2
Description
Intervention group: open flap surgery technique, In this group, after tooth extraction, first a crestal incision and two vertical incisions are made, and the flap is raised in full thickness until 2 to 3 mm of the buccal bone is exposed. For greater flexibility of the flap and the possibility of closing the surgical site, a periosteal incision is given. The steps of implantation, the type of implant and the type of bone graft will be similar to the first group. CBCT images using a planmeca device (finland) are prepared before surgery (T0) and 6 months (T1) after recovery in order to evaluate the amount of buccal bone plate regeneration.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Dental School
Full name of responsible person
Sima Sangchouli
Street address
Palestine Ave، Noshirvani Blvd
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3229 1408
Fax
+98 11 3229 1093
Email
sima_sangchouli@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mahdi Rajabnia
Street address
Nurse Ave, University Square, Murad Beg Town
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3239 1408
Fax
+98 11 3229 1093
Email
sima_sangchouli@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Majid Fereyduni
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Periodontology and Implantology
Street address
Nurse Ave، University Square، Morad Beg Town
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3229 1408
Email
golpasha@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Majid Fereyduni
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Periodontology and Implantology
Street address
Nurse Ave, University Square, Morad Beg Town
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3229 1408
Email
golpasha@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Majid Fereyduni
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Periodontology and Implantology
Street address
Nurse Ave، University Square، Morad Beg Town
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3229 1408
Email
golpasha@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be identified and stored by assigning a code
When the data will become available and for how long
After finishing the study and publishing its article
To whom data/document is available
Researchers and academics
Under which criteria data/document could be used
Due to the acquisition of the code of ethics of researchers by the Deputy of Research and Technology of Babol University of Medical Sciences, the documents will be usable
From where data/document is obtainable
Dr. Majid Fereduni، Babol University of Medical Sciences
What processes are involved for a request to access data/document
Checking the eligibility of the applicant and having the code of ethics will be done by an academic center.