Protocol summary

Study aim
Determining the effect of local dexamethasone injection after implant placement surgery (Immediate implant)
Design
A clinical trial with a control group, with parallel groups, double-blinded, phase 3 on 60 patients, randomized by block randomization method
Settings and conduct
All patients(both groups) receive the same surgery and drug except dexamethasone. An experienced surgeon with the same technique in the special clinic of the Sari Dental Faculty performs all surgeries. The person who follows the patients and records their pain and swelling levels will not be aware of the patient's group, and only the surgeon will be aware of the patient's groups.Also, none of the patient and control groups know whether the local injection was done. Patients' pain will be evaluated by VAS (Visual Analogue Scale), criteria and accompanying clinical conditions will be described for the patient, and according to the classification made by Pasqualini, patients will rate their pain and swelling from 0 to 5.These tests will be done within 48 hours,4 days later and then 7 days after the surgery through a phone call.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individulas aged 18 to 60 years who have no threatening systemic disease or allergy to dexamethasone. Exclusion criteria include pregnant people, threatening systemic disease, weak immune system, AIDS, sensitivity to the drugs used in the study, and recent use of antibiotics and anti-inflammatory drugs.
Intervention groups
In the control group, subjects will not receive any corticosteroids. In the intervention group, immediately after suturing, dexamethasone will be injected with the help of an insulin syringe in the depth of the vestibule adjacent to the implanted tooth, and 1/3 vials of topical dexamethasone (8 mg from Alborz Darou Pharmaceutical Co.) will be used.
Main outcome variables
Pain; Swelling; Satisfaction with surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221228056958N1
Registration date: 2023-02-18, 1401/11/29
Registration timing: prospective

Last update: 2023-02-18, 1401/11/29
Update count: 0
Registration date
2023-02-18, 1401/11/29
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
2023-02-20, 1401/12/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of local dexamethasone injection after immediate implant placement
Public title
The Effect of local dexamethasone injection after immediate implant placement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People from 18 to 60 years old
Exclusion criteria:
Pregnant people, , ,, sensitivity to the drugs used in the study, and . Threatening systemic disease AIDS Weak immune system Recent use of antibiotics and anti-inflammatory drugs Cushing's syndrome Cataracte Psychosis Acute or chronic infection Tuberculosis (active and treated) Oral herpes simplex
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization (blocks of 4); Individual Randomization tool: The software of random allocation 2 Procedure of making a random sequence and hiding it: Using the software, codes A and B will be generated, where code A means the application of the dexamethasone group and code B means the application of the control group for each individual. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the doctor will open the envelope and apply the desired treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who follows the patients and records their pain and swelling levels will not be aware of the patient's group, and only the surgeon will be aware of the patient's groups. Also, none of the patient and control groups know whether the local injection was done(There is a placebo).
Placebo
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, Jouybar Intersection, Imam Sqr.
City
Sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2022-12-10, 1401/09/19
Ethics committee reference number
IR.MAZUMS.REC.1401.398

Health conditions studied

1

Description of health condition studied
Pain and swelling after immediate implant placement surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain score
Timepoint
2 , 4 and 7 days after surgery
Method of measurement
Visual Analogue Scale

2

Description
Swelling score
Timepoint
2 , 4 and 7 days after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For local anesthesia, lidocaine 2% with epinephrine 1:100,000 is used. All patients (both groups) receive the same surgery and drug except dexamethasone. The implant used in the Bone level study will be with SLA level, two-stage surgery (screw closure), and cover the implant with gum. The minimum amount of initial stability for implants was considered to be 15 newtons. If the distance between the implant and the extracted tooth cavity is more than 2 mm, it is filled with xenograft grafting material. After completing the surgery and washing the area with normal saline, the incision site is sutured with 0-5 nylon thread and immediately injecting a dose of dexamethasone (1/3 vial of dexamethasone 8 mg Alborz Daro Pharmaceuticals) with an insulin syringe in the depth of the vestibule near the implanted tooth is done. Prescription medicine is amoxicillin 500 every 8 hours for 1 week and 0.2% chlorhexidine mouthwash (twice a day).
Category
Treatment - Drugs

2

Description
Control group: Anesthesia and surgery procedures and prescribed drugs are similar to the intervention group, but dexamethasone is not injected and instead, 1/3 vial of 2% lidocaine with epinephrine 1:100,000 is injected with an insulin syringe in the depth of the vestibule adjacent to the implanted tooth.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari Dental Clinic
Full name of responsible person
Najmeh Sadat Valed Saravi
Street address
Khazar Square, Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
1133240003
Phone
+98 11 3324 4014
Email
darman@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram EbrahimNejad
Street address
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?
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
Najmeh Sadat Valed Saravi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Farhang 16, Farhang St
City
Sari
Province
Mazandaran
Postal code
1133314614
Phone
+98 11 3331 4614
Email
Dr.valed@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Najmeh Sadat Valed Saravi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Farhang 16, Farhang St
City
Sari
Province
Mazandaran
Postal code
1133314614
Phone
+98 11 3331 4614
Email
Dr.valed@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Najmeh Sadat Valed Saravi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Farhang 16, Farhang St
City
Sari
Province
Mazandaran
Postal code
1133314614
Phone
+98 11 3331 4614
Email
Dr.valed@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
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