Comparative evaluation of papilla reconstruction between adjacent implants using bone and connective tissue graft in patients referring to Periodontics Department of Hamadan School of Dentistry
Aim: Comparison of bone and connective tissue graft procedures in papilla reconstruction between adjacent implants bone and connective tissue graft in patients referring to Periodontics Department of Hamedan School of Dentistry Design: Single blinded randomized clinical trial Setting: The eligible patients who are candidate to replacement of adjacent implants will be assigned to two different block randomized treatment groups of bone and connective tissue graft. Inclusion criteria: missing two adjacent teeth so that there is the possibility of placing two implants in bone site; at least 3 months has been passed since the area being edentulous Exclusion criteria: periodontal plastic surgery or Bone graft history in the area; presence of any systemic disease (Including uncontrolled diabetes, osteomyelitis) that may affect implant placement or soft tissue management; smoking; pregnancy. For all patients during surgery anesthetic injection, flap and drilling steps in implant site will be done. Intervention (a): FDBA bone block that has been immersed in saline will be used and for adaptation to area will be trimmed by scissor and fixed in place with titanium screw. Intervention (b): The palatal mucosa between canine and mesial line angle of first molar will be used as source of connective tissue. the graft will be placed on top of the alveolar bone between two implants and then sutured with an absorbable suture. Primary outcome: Papilla height based on papilla index(Jemt) Secondary outcome: Vertical distance between tip of papilla and alveolar crest based on radiographic evaluation using radiopaque indicator
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072414142N1
Registration date:2013-08-08, 1392/05/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-08, 1392/05/17
Registrant information
Name
Shilan Razaghi
Name of organization / entity
Hamedan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 1084
Email address
sh.razaghi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-06-20, 1392/03/30
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of papilla reconstruction between adjacent implants using bone and connective tissue graft in patients referring to Periodontics Department of Hamadan School of Dentistry
Public title
Comparison of soft tissue reconstruction between adjacent implants using bone and connective tissue graft in patients missing two adjacent teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: missing two adjacent tooth so that there is the possibility of placing two implants in bone site; the area is edentulous for at least 3 months Exclusion criteria: periodontal plastic surgery or Bone graft history in the area; presence of any systemic disease (Including uncontrolled diabetes, osteomyelitis) that may affect implant placement or soft tissue management; smoking; Pregnancy
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
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, Hamadan University of Medical Sciences
Street address
Postcode: 65178-38377, Periodontics Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
65178-38377
Approval date
2013-06-12, 1392/03/22
Ethics committee reference number
16/35/9/757/پ/د
Health conditions studied
1
Description of health condition studied
missing two adjacent teeth, with bone resorption and papilla loss in the area
ICD-10 code
k08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
Papilla height based on papilla index
Timepoint
3 months after intervention,6 months after intervention
Method of measurement
Qualitative determination of vertical distance between the tip of papilla to the line connecting Zenith of soft tissue margin at adjacent crowns based on grading system of Papilla index (Jemt).This index is classified into five grades (0,1,2,3,4) .
Secondary outcomes
1
Description
Distance from the tip of the papilla to the alveolar crest
Timepoint
3 months after intervention,6 months after intervention
Method of measurement
Quantitative measurement of vertical distance from the tip of papilla between two implants to the alveolar crest in periapical radiography using radiopaque indicator in millimeters.
Intervention groups
1
Description
FDBA bone block that has been immersed in saline will be used and for adaptation to the area will be trimmed by scissor and fixed in place with titanium screw.
Category
Treatment - Surgery
2
Description
The palatal mucosa between the canine and the mesial line angle of first molar will be used as the source of connective tissue. Connective tissue graft harvested from the palate by making a single incision parallel and at a distance of 2mm from the gingival margin using a scalpel with a size 15 blade. After horizontal and vertical incisions the graft will be separate and donor site sutured.The graft will be placed on top of the alveolar bone between two implants and then sutured with an absorbable suture.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Dr Syed Reza Arabi
Street address
Postcode: 65178-38377, Periodontics Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Heidar Tavilani
Street address
Postcode: 65178-518, School of Medicine, Shahid Fahmideh Street, Hamadan
City
Hamedan
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 and technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr Syed Reza Arabi
Position
Assistant
Other areas of specialty/work
Street address
Postcode: 6517838377, Periodontics Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
6517838377
Phone
+98 81 1838 1086
Fax
+98 811838105
Email
sr_arabi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Syed Reza Arabi
Position
Assistant
Other areas of specialty/work
Street address
Postcode: 6517838377, Periodontics Department, School of Dentistry, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
6517838377
Phone
+98 81 1838 1086
Fax
+98 81 1838 1085
Email
sr_arabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Shilan Razaghi
Position
Periodontics resident
Other areas of specialty/work
Street address
Postcode: 6517838377, Periodontics Department, School of Dentistry, Shahid Fahmideh Street, Hamadan