Protocol summary

Summary
Objectives: Clinical evaluation and comparison of keratinized gingiva around implants following second stage of implant surgery by diode laser and punch technique by scalpel Design: Randomized controlled clinical trial on 40 patients receiving implant treatment at Kerman Dental School, twenty patients in punch by scalpel group and 20 patients in diode laser group, single blind (outcome evaluator) , simple randomization by coin tossing Setting and conduct: measuring the keratinized gingival height at surgery time, and then weekly for four weeks post surgery Inclusion criteria: Patients candidate for second stage of implant surgery through punch technique Exclusion criteria: Patient's incompliance Intervention: Performing punch technique by scalpel or application of diode laser for implant exposure at second stage of implant surgery Time of intervention: 2-4 months after implant placement Primary outcome: Dimensions of keratinized gingiva Secondary outcome: Pain

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409175305N4
Registration date: 2017-06-14, 1396/03/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Mohammad Mohammadi
Name of organization / entity
Kerman Dental School
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 9021
Email address
m_mohammadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman Dental and Oral Research Center; Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Evaluation Of Keratinized Gingiva After Implant Exposure Using Diode Laser And Punch Technique
Public title
Evaluation of Gingival Dimension After Two Different Techniques for Second Stage of Implant Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of sufficient keratinized gingiva, as at least 9mm of keratinized tissue would be available; Absence of bone loss assessed through periapical radiography prior to the second stage of implant surgery; Patient cosent Exclusion criteria: Patient's incompliance
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Research Center, Somayye crossroad, Shariati st.
City
Kerman
Postal code
Approval date
2015-10-31, 1394/08/09
Ethics committee reference number
IR.KMU.REC.1394.288

Health conditions studied

1

Description of health condition studied
Gingival recession
ICD-10 code
K06.0
ICD-10 code description
Gingival recession (generalized)(localized)(postinfective)(post-operative)

Primary outcomes

1

Description
keratinized gingiva dimension
Timepoint
At surgery time, and then weekly for four weeks post surgery
Method of measurement
By periodontal probe

Secondary outcomes

1

Description
Pain
Timepoint
One week after surgery
Method of measurement
Visual analogue scale (VAS)

Intervention groups

1

Description
intervention group: implant exposure by diode laser
Category
Treatment - Surgery

2

Description
Control group: implant exposure through punching by scalpel
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodontics Dept.,kerman Dental School
Full name of responsible person
Dr. Mohammad Mohammadi
Street address
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Kerman University of Medical Science
Full name of responsible person
Dr. Shahravan
Street address
Somayye crossroad, Shariati st.
City
kerman
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, Kerman University of Medical Science
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
Periodontics Department, Kerman Dental School
Full name of responsible person
Dr. Mohammad Mohammadi
Position
Assistant professor of Periodontology
Other areas of specialty/work
Street address
Kerman Dental School, Shafa street
City
kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
m_mohammadi@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman Dental School
Full name of responsible person
Dr.Mohammad mohammadi
Position
Assistant professor of periodontology
Other areas of specialty/work
Street address
Periodontics department, Kerman Dental Shool, Shafa street
City
kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
m_mohammadi@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman Dental School
Full name of responsible person
Dr. Mohammad Mohammadi
Position
Asstistant professor of periodontology
Other areas of specialty/work
Street address
Periodontics department, Kerman Dental School, Shafa street
City
kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Fax
Email
mmohammadi28@yahoo.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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