Protocol summary

Summary
28 participants in both control and test groups (14 patients in each group) receive mucogingival surgery to increase the width of attached keratinized peri-implant mucosa. They should have at least one implant lacking attached mucosa on the buccal side. Baseline measurements includes the width of keratinized gingiva in the buccal side of implants (as primary outcome), plaque index, gingival index and probing pocket depth in adjacent natural teeth. Furthermore, surface texture and color are recorded using photographs. For both groups, the recipient bed is prepared using a surgical blade (number 15), beginning from the mucogingival line, as a split thickness periosteal bed. Muscle attachments are incised to create a periosteal bed. The mucosal flap is sutured to the buccal mucosa or it is removed. For the participants in the control group, a free gingival graft is harvested from the palatal area. The graft size is determined using an aluminum foil placed on the recipient bed. The gingival graft is stabilized by 4-0 vicryl absorbable sutures. In the test group, an amniotic membrane graft is cut to the appropriate size, then, it is fixated using the similar sutures. Immediately after homeostasis, the width measurement and clinical measurements are repeated. The measurements are repeated after the 1st, 2nd, 6th and 12th weeks. The participants are asked to fill the VAS pain related questionnaire in every recall sessions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101621069N2
Registration date: 2017-03-16, 1395/12/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-16, 1395/12/26
Registrant information
Name
zeinab kadkhoda
Name of organization / entity
Tehran university of medical sciences,faculty of dentistry.
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5801
Email address
zkadkhoda@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
research center of the Iranian Tissue Bank
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of amnion allograft with free gingival graft to improve the attached mucosa around dental implants
Public title
amnion allograft for increasing the width of peri-implant attached mucosa
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients age more than 18 years; systemic and periodontal health; at least one implant with less than 1 mm attached mucosa after the stage 1 implant insertion surgery; favorable plaque control (less than 20% olery plaque index); patients should be able to afford the related procedures.
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of the Tehran University of Medical Sciences
Street address
6th floor, central organization of TUMS, keshavarz street, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-02-04, 1395/11/16
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1608

Health conditions studied

1

Description of health condition studied
lack of attached mucosa around dental implants
ICD-10 code
K06.0
ICD-10 code description
Gingival recession

Primary outcomes

1

Description
width of attached peri-implant mucosa
Timepoint
before surgery, immediately after surgery, after the 1st, 2nd, 6th and 12th postoperative weeks
Method of measurement
measurement of the distance between mucosal margin to the mucogingival line in the midbuccal of each implants using UNC-15 periodontal probe - probing depth

Secondary outcomes

1

Description
post-operative pain
Timepoint
after the 1st, the 2nd, the 6th and the 12th postoperative weeks
Method of measurement
visual analogue scale (VAS)

Intervention groups

1

Description
In the control group, participants recieve free gingival graft (from palate) to increase the width of attached mucosa around implants. In the test group, patients are treated with amniotic allogenic membrane for the same purpose.
Category
Treatment - Surgery

2

Description
in test group, the attached peri-implant mucosa is augmented using allogenic amniotic membrane. in the control group, free gingival graft from the palatal mucosa is performed to increase the attached peri-implant mucosa
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
postgraduate section, department of periodontology, school of dentistry, TUMS
Full name of responsible person
Dr Hossein Babazade
Street address
3rd floor, school of dentistry
City
north karegar street

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian Tissue Bank Research Center
Full name of responsible person
Masoud Younesian
Street address
Room no.601, 6th floor, Central Organization TUMS, Ghods street, Keshavarz street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian Tissue Bank Research Center
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
school of dentistry, TUMS
Full name of responsible person
Dr Babazade
Position
post graduate student
Other areas of specialty/work
Street address
3rd floor, school of dentistry, north karegar street
City
Tehran
Postal code
Phone
+98 21 8835 1170
Fax
Email
hossein.babazade89@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Dentistry, TUMS
Full name of responsible person
Dr Zeinab Kadkhoda
Position
Associate Professor
Other areas of specialty/work
Street address
3rd floor, school of dentistry, North Karegar
City
Tehran
Postal code
Phone
+98 21 8835 1170
Fax
Email
zkadkhoda@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
school of Dentistry, TUMS
Full name of responsible person
Dr Hoori Aslroosta
Position
assistant professor
Other areas of specialty/work
Street address
3rd floor, school of dentistry, TUMS, North Karegar street
City
Tehran
Postal code
Phone
+98 21 8835 1170
Fax
Email
roosta.hoori@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
Loading...