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Studying the effect of platelet-rich fibrin (L-PRF) plug on the level of alveolar crest keratinized gingiva in immediate implant placement

Protocol summary

Study aim
Studying the effect of platelet-rich fibrin plug (L-PRF) on the formation of alveolar crest keratinized gingiva in immediate implant placement
Design
clinical trial, With control group, parallel groups, single-blind, randomized, phase 3 on 60 patients. Random Allocation software was used for randomization.
Settings and conduct
The study will be conducted in the special dental clinic of Mazandaran University of Medical Sciences (Toubi Clinic). The implant used in the study will be of Snucone brand, made in Korea, with SLA level, along with two-stage surgery (cover screw closing) and covering the implant with gingiva. For the control group, after placing the implant, no additional step will be performed. In the intervention group, after placing the implant, platelet-rich fibrin (L-PRF) will be placed on it. Blinding with random allocation software The researcher is blind
Participants/Inclusion and exclusion criteria
Inclusion criteria included subjects with systemic health (class 1 according to the ASA classification); colleagues, with good oral hygiene and no acute infection; patients with teeth due to terminal periodontal disease, root fracture, or root resorption indicated for extraction; and patients who wanted to visit again; In addition, patients should not have untreated periodontal disease.
Intervention groups
The implant used in the study will be of Snucone brand, made in Korea, with SLA level, along with two-stage surgery (cover screw closing) and covering the implant with gingiva. For the first group, no additional steps will be taken after placing the implant. In the second group, after placing the implant, platelet-rich fibrin (L-PRF) will be placed on it.
Main outcome variables
Keratinized gingiva width; keratinized gingiva thickness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221228056958N2
Registration date: 2024-06-03, 1403/03/14
Registration timing: registered_while_recruiting

Last update: 2024-06-03, 1403/03/14
Update count: 0
Registration date
2024-06-03, 1403/03/14
Registrant information
Name
Najmeh Sadat Valed Saravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3331 4614
Email address
n.valed@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-17, 1402/11/28
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of platelet-rich fibrin (L-PRF) plug on the level of alveolar crest keratinized gingiva in immediate implant placement
Public title
Effect of platelet rich fibrin on soft tissue quality after immediate implant placement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with systemic health (class 1 according to the ASA classification) cooperative good oral hygiene and absence of acute infection Patients with teeth indicated for extraction due to terminal periodontal disease, root fracture, or root resorption Patients who were willing to visit again. Patients should not have untreated periodontal disease.
Exclusion criteria:
patients with compromised systemic conditions (ASA 2,3,4,5,6) inadequate oral hygiene and presence of acute infection Patients without teeth indicated for extraction or unwilling for implant treatment Patients unwilling to visit again Patients with untreated periodontal disease Uncooperative
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: randomization will be block (blocks of 4) and individually Randomization tool: random allocation software 2 Using the software, codes A and B will be generated, where code A means applying the intervention group and code B means applying the control group for each person. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. After the arrival of each patient, the doctor will open the envelope and apply the intended treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher is unaware of the type of treatment performed on the patient, and this information is kept with the surgeon.
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
Sari, Jouybar three ways, Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2025-02-11, 1403/11/23
Ethics committee reference number
IR.MAZUMS.REC.1402.618

Health conditions studied

1

Description of health condition studied
Lack of keratinized gingiva around the implant
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Keratinized gingiva width
Timepoint
Before tooth extraction, 2 weeks after healing abutment placement
Method of measurement
Using a periodontal probe and the Rolling technique

2

Description
Keratinized gingiva thichness
Timepoint
Before tooth extraction, 2 weeks after healing abutment placement
Method of measurement
Using a Williams periodontal probe that goes into the tissue until it reaches the bone.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The implant used in the study will be of Snucone brand, made in Korea, with SLA level, along with two-stage surgery (cover screw closing) and covering the implant with gingiva. The implant will be placed at the level of the crest or at most 0.5 mm below the corset (if the thickness of the corset is less than 1 mm and there is a possibility of resorption). After placing the implant, it will be placed on it as a platelet and leukocyte-rich fibrin plug (L-PRF). The surgeon will administer platelet and leukocyte-rich fibrin (L-PRF).
Category
Treatment - Surgery

2

Description
Control group: The implant used in the study will be of Snucone brand, made in Korea, with SLA level, along with two-stage surgery (cover screw closing) and covering the implant with gingiva. The implant will be placed at the level of the corset or at most 0.5 mm below the crest (if the thickness of the corset is less than 1 mm and there is a possibility of resorption). In the first group, after placing the implant, an additional step will not be performed, and the flap will be displaced coronally just to avoid exposing the implant.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Tooba Dental Clinic
Full name of responsible person
Dr. Najme Sadat Valed Saravi
Street address
Tooba dental clinic, khazar blvd., sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
n.valed@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahim Nezhad
Street address
Mazandran university of medical sciences, jooybar 3 ways, sari
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
n.valed@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Dr. Najme Sadat Valed Saravi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
mazandaran university of medical scienses, jooybar 3 ways, sari
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
n.valed@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Najme Sadat Valed Saravi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
mazandaran university of medical scienses, jooybar 3 ways, sari
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
n.valed@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Najme Sadat Valed Saravi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
mazandaran university of medical scienses, jooybar 3 ways, sari
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
n.valed@mazums.ac.ir

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
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