Protocol summary

Summary
The aim of this research is to compare the analgesic effects of Novafen, Ibuprofen and Acetaminophen after implant surgery in the maxillary posterior region. The research method of the present investigation is randomized double-blinded approach. In this study, 36 patients (including three groups, n=12) referring to the Department of Implant, Faculty of Dentistry, Tabriz University of Medical Sciences, will be selected as statistical population of the study. Inclusion criteria of the study consist of conditions such as favorable hard and soft tissue in the implant region and no need for adjunctive surgeries such as sinus lift procedure. Exclusion criteria consist of sensitivity to the study drugs and taking any analgesics at least four hours before implant surgery. Group one will receive Ibuprofen tablets (400 mg every eight hours); group 2 will receive Acetaminophen tablets (500 mg every 8 hours); and group 3 will receive Novafen capsules (containing 325 mg of Acetaminophen, 200 mg of Ibuprofen and 40 mg of Caffeine, every eight hours). The first dose will be given immediately after surgery and the second dose will be taken 8 hours after the first dose. Using Visual Analgesic Scale (VAS), the patients’ pain will be measured 3 hours after surgery and then the pain will be measured by Verbal Rating Scale (VRS) within 12, 24 and 48 hours after surgery. The main variable is pain relief after implant surgery by the three drugs mentioned above, which will be evaluated at 3-, 12-, 24- and 48-hour postoperative intervals.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071614440N2
Registration date: 2016-08-10, 1395/05/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-10, 1395/05/20
Registrant information
Name
Alli Zarandi
Name of organization / entity
Dental Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5921
Email address
zarandia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-07-17, 1395/04/27
Expected recruitment end date
2016-08-07, 1395/05/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Novafen, Iboprofen and Acetaminophen on pain relief after implant surgeries in posterior region of maxilla
Public title
Comparison of effect of Novafen, Iboprofen and Acetaminophen on pain relief after implant surgeries in posterior region of the upper jaw
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria of the study: Informed consent for being included in the study; Candidate patients of implant surgery aged 18‒40 years; The hard and soft tissue region should be favorable for implant; Implant replacement without any adjunctive surgery Exclusion criteria of the study: Suffering from a systemic disease; Addictions to alcohol or smoking or every psychotropic substance; Diagnosed sensitivity to NSAIDs, Caffeine or Acetaminophen; Consuming drugs interfering with Ibuprofen, Novafen or Acetaminophen; Receiving any type of analgesics at least four hours before implant surgery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All drugs were selected from the same pharmaceutical company, packed in similar capsules in the Faculty of Pharmacology of Tabriz and then packed in uniform tins by a third person, classified in three groups of A, B and C. All the packs were labeled and coded randomly and each patient will receive a pack before implant surgery. The randomized codes were hidden from the researchers, nurses and the patients and will be kept in a safe place until the end of the study.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics Committee of Tabriz University of Medical Sciences,Vice Chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Postal code
51665-118
Approval date
2016-06-15, 1395/03/26
Ethics committee reference number
IR.TBZMED.REC.1395.215

Health conditions studied

1

Description of health condition studied
implant surgery
ICD-10 code
ـ
ICD-10 code description
ـ

Primary outcomes

1

Description
Pain Relief after implant surgery
Timepoint
3h,12h, 24h and 48h after implant surgery
Method of measurement
VAS( Visual Analgesic Scale) 3h after implant surgery; VRS( Verbal Rating Scale) 12h,24h and 48h after implant surgery

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1:Ibuprofen 400 milligram tablet, immediately after the surgery and every 8 hours for 2 days
Category
Treatment - Drugs

2

Description
Intervention group2: Novafen capsule (containing acetaminophen 325 mg, ibuprofen 200 mg and caffeine 40 mg) immediately after the surgery and every 8 hours for 2 days
Category
Treatment - Drugs

3

Description
Control group: Acetaminofen 500 miligram tablet, immediately after the surgery and every 8 hours for 2 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Implant of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
ali zarandi
Street address
Department of Implant, Tabriz Dental Faculty, Tabriz University of Medical Sciences
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Vice Chancellor for Research, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
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 Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Ali Zarandi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontics, Tabriz Dental Faculty, Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Postal code
5166614713
Phone
+98 41 1329 4312
Fax
+98 41 1334 6977
Email
dr.alizarandi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Ali Zarandi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Orthodontics, Tabriz Dental Faculty, Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Postal code
5166614713
Phone
+98 41 1329 4312
Fax
+98 41 1334 6977
Email
Dr.alizarandi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Ali Zarandi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontics, Tabriz Dental Faculty, Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Postal code
5166614713
Phone
+98 41 1329 4312
Fax
+98 41 1334 6977
Email
Dr.alizarandi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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