IRCT | Evaluation of the effect of antibiotic prophylaxis on clinical and patient reported outcome and inflammation-related indicators of oral implant therapy with guided bone regeneration.

Protocol summary

Study aim: Evaluation of the effect of antibiotic prophylaxis on clinical and patient reported outcome and inflammation-related indicators of oral implant therapy with guided bone regeneration.
Design: Clinical trial with control group, double-blind, with parallel groups, randomized, phase 3 on100 patients. A random number table was used for randomization using closed envelopes.
Settings and conduct: A total of 100 patients referred to Mashhad Dental School who are applying for implants and at the same time need a bone graft in the form of GBR will be included in this study. For blindness with the help of random number and code for each patient, a person other than the patient surgeon puts the type of intervention in the envelope. data analyzer and the Outcome assessor are blinded in this study. In all groups, one type of graft and membrane is used However, in the intervention group, in addition to routine treatment patients will also have to take 2gr of amoxicillin one hour before work. One week later, pain intensity will be assessed by the visual analog scale and bleeding, swelling and hematoma assessment check-list based on the patient's Yes or No answer.
Participants/Inclusion and exclusion criteria: Inclusion criteria:1- An age range 20 to 50 years 2-The extent of the lesion is limited 3-No previous surgical procedures have been initiated in the specific area 4-Absence of systemic disease 5-Non smoker 6-Do not take drug interfere with the treatment process 7- Dehiscence defects in buccal surface of the implant exclusion criteria:1-Do not refer 2-Patients who are allergic to amoxicillin 3-The presence of severe infection 4- Opening the edge of the wound.
Intervention groups: Intervention group: In addition to routine treatment, patients receive 2gr amoxicillin an hour before work. control group: Patients will receive routine treatment.
Main outcome variables: Pain, Bleeding, Hematoma and swelling

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20140817018834N8

Registration date: 2021-06-10, 1400/03/20

Registration timing: prospective

Last update: 2021-06-10, 1400/03/20

Update count: 0
Registration date: 2021-06-10, 1400/03/20

Registrant information: Name

Nahid Nasrabadi

Name of organization / entity

Shahid Sadoughi University of Medical Sciences of Yazd

Country

Iran (Islamic Republic of)

Phone

+98 35 1621 2623

Email address

nasran@mums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-06-13, 1400/03/23
Expected recruitment end date: 2021-10-23, 1400/08/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluation of the effect of antibiotic prophylaxis on clinical and patient reported outcome and inflammation-related indicators of oral implant therapy with guided bone regeneration.

Public title: Evaluation of the effect of antibiotic prophylaxis in implant surgery with guided bone regeneration.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

• An age range of 20 to 50 years • The extent of the lesion (horizontal bone augmentation) is about one or two teeth • No previous surgical procedures have been initiated in the specific area • The patient's informed consent •Absence of systemic diseases that interfere healing process, such as diabetes • Non smoker •Do not take drugs interfere with the treatment process, such as corticosteroids • Dehiscence defects in buccal surface of the implant

Exclusion criteria:

• Do not refer for routine follow up visits • Patients who are allergic to amoxicillin • The presence of severe infection in the oral cavity • Wound opening during bone transplantation surgery
Age: From 20 years old to 50 years old
Gender: Both

Phase

3

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 100

Randomization (investigator's opinion)

Randomized

Randomization description

The randomization method will be block. Patients will be randomly allocated in to the intervention and control groups by block randomization technique. A number of two blocks (A and B) will be considered. With the help of random numbers, a random number will be assigned to each group and this will determine the type of intervention. For blindness with the help of random number and code for each patient, a person other than the patient surgeon puts the type of intervention in the envelope. The type of intervention (use of prophylaxis or not ) is recommended to the patient .

Blinding (investigator's opinion)

Double blinded

Blinding description

Due to the design of the study, it is not possible to blind the participants, principal investigator and clinic staff, and Each person's data are made available to the data analyzer and the Outcome assessor without knowing the case group or being in control.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Mashhad University of Medical Sciences_Mashhad faculty of dentistry

Street address

Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad

City

Mashhad

Province

Razavi Khorasan

Postal code

9177948959
Approval date: 2021-05-12, 1400/02/22
Ethics committee reference number: IR.MUMS.DENTISTRY.REC.1400.035

Health conditions studied

1

Description of health condition studied: Horizontal alveolar bone defects.
ICD-10 code: k08.2
ICD-10 code description: Atrophy of edentulous alveolar ridge

Primary outcomes

1

Description: pain
Timepoint: 1-3-7 days after surgery
Method of measurement: The patient is asked about the amount of pain by telephone using the visual analogue scale index on the first, third, and seventh days, and the patient is asked to rate their pain experience on a scale from 0 to 10 .

2

Description: swelling
Timepoint: 1_3_7 days after surgery.
Method of measurement: On the first, third and seventh day, the patient is asked about the presence or absence of swelling. due to special conditions in COVID-19 prevalence and attracting patient involvement and cooperation, On the third day, the patient will be examined remotely by sending a full face photo.

3

Description: bleeding
Timepoint: 1_3_7 days after surgery.
Method of measurement: On the first, third and seventh day, the patient is asked about the presence or absence of bleeding. due to special conditions in COVID-19 prevalence and attracting patient involvement and cooperation, On the third day, the patient will be examined remotely by sending a full face photo.

4

Description: hematoma
Timepoint: 1_3_7 days after surgery.
Method of measurement: On the first, third and seventh day, the patient is asked about the presence or absence of hematoma. due to special conditions in COVID-19 prevalence and attracting patient involvement and cooperation, On the third day, the patient will be examined remotely by sending a full face photo.

Secondary outcomes

1

Description: implant survival
Timepoint: 3 months after surgery
Method of measurement: Clinical and radiography examination

Intervention groups

1

Description: Intervention group: In patients who are candidates for implant placement, the guided bone regeneration treatment will be performed using one type of membrane and one type of bone graft. In this group 2 gr amoxicillin will be prescribed one hour before treatment. After surgery, amoxicillin 500 mg (Abidi) every 8 hours for 7 days and ibuprofen 400 mg every 6 hours for 5 days will be prescribed.
Category: Treatment - Drugs

2

Description: Control group: In patients who are candidates for implant placement, the guided bone regeneration treatment will be performed using one type of membrane and one type of bone graft. In this group, no prophylactic antibiotic will be prescribed before treatment. after surgery, amoxicillin 500 mg (Abidi) every 8 hours for 7 days and ibuprofen 400 mg every 6 hours for 5 days will be prescribed.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Mashhad faculty of dentistry

Full name of responsible person

Nahid Nasrabadi

Street address

Mashhad of faculty of dentistry, Vakil Abad Blv, Mashhad, Razavi khorasan province

City

Mashhad

Province

Razavi Khorasan

Postal code

9177948959

Phone

+98 51 3882 9501

Fax

+98 51 3882 9500

Email

nasran@mums.ac.ir

1

Sponsor: Name of organization / entity

Vice Chancellor for research of Mashhad University of Medical Sciences

Full name of responsible person

Mohsen Tafaghodi

Street address

Deputy of Technology and Research, Qureshi building, next to Hoveyze cinema, Daneshgah Avenue.

City

Mashhad

Province

Razavi Khorasan

Postal code

9138813944

Phone

+98 51 3841 1538

Fax

+98 51 3843 0249

Email

tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Vice Chancellor for research of Mashhad 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

Mashhad University of Medical Sciences

Full name of responsible person

Nahid Nasrabadi

Position

َAssistant Professor

Latest degree

Specialist

Other areas of specialty/work

Dentistry

Street address

Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad, Razavi khorasan province

City

Mashhad

Province

Razavi Khorasan

Postal code

9177948959

Phone

+98 51 3882 9501

Fax

+98 51 3882 9500

Email

nasran@mums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Nahid Nasrabadi

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Dentistry

Street address

Mashhad faculty of dentistry, Vakil Abad Blv , Mashhad, Razavi khorasan province

City

Mashhad

Province

Razavi Khorasan

Postal code

9177948959

Phone

+98 51 3882 9501

Fax

+98 51 3882 9500

Email

nasran@mums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Nahid Nasrabadi

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Dentistry

Street address

Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad, Razavi khorasan province

City

Mashhad

Province

Razavi Khorasan

Postal code

9177948959

Phone

+98 51 3882 9501

Fax

+98 51 3882 9500

Email

nasran@mums.ac.ir

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: The data is related to the main consequence after unidentifiable people are shared.
When the data will become available and for how long: 6 month after printing the results.
To whom data/document is available: Researchers working in academic and scientific institutions.
Under which criteria data/document could be used: If you are to submit a article to a journal, they will be asked to receive the data.
From where data/document is obtainable: Person responsible for scientific study. nasran@mums.ac.ir
What processes are involved for a request to access data/document: Sending an email to the given address and waiting time to receive a response less than a month.
Comments

Evaluation of the effect of antibiotic prophylaxis on clinical and patient reported outcome and inflammation-related indicators of oral implant therapy with guided bone regeneration.