Evaluating the effect of hyaloronic acid injection on recounstruction of interdental papilla which has been lost
Design
20 interdental papilla which has deficiency in 5 patients
Settings and conduct
Patients referring to Periodontics department of Shiraz Dental School, who has interdental papilla deficiency, will be included in this study. Hyaloronic acid will be injected at interdental papilla and the area of interdental space will be measured before and 3, 6 months after injection.
Participants/Inclusion and exclusion criteria
Patients whith plaque index below 20%; no caries; no smoking; no systemic disease; no deep pockets and healthy perodontium
Intervention groups
Hyaloronic acid injection in interdental papilla which has been lost
Main outcome variables
Increasing interdental papilla's volume and it's area in photography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200419047132N1
Registration date:2020-06-04, 1399/03/15
Registration timing:retrospective
Last update:2020-06-04, 1399/03/15
Update count:0
Registration date
2020-06-04, 1399/03/15
Registrant information
Name
Ali Azadikhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 9957
Email address
a2.azadikhah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
2019-11-27, 1398/09/06
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2020-06-06, 1399/03/17
Scientific title
Evaluation of hyaluronic acid injection’s effect on reconstruction of 20 reduced interdental papilla in patients who apply Shiraz dental school
Public title
Evaluation of hyaluronic acid injection’s effect on reconstruction of reduced interdental papilla
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have papilla recession in anterior of maxilla
Plaque index bellow 20%
Exclusion criteria:
Gingivitis or periodontitis at the region
Smoking
Taking drugs which cause gingival enlargement
Systemic disease which effects periodontal status
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
5
More than 1 sample in each individual
Number of samples in each individual:
4
reduced interdental papilla
Actual sample size reached:
5
More than 1 sample in each individual
Actual sample size in each individual:
4
Reduced interdental papilla loss
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Use of Acid hyaloronic gel with higher viscosity, injection in 2 points of papilla
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
ِDentistry faculty, Ghomabad, Ghasraldasht Ave.
City
Shiraz
Province
Fars
Postal code
7185981633
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.SUMS.DENTAL.REC.1399.030
Health conditions studied
1
Description of health condition studied
Interdental papilla loss
ICD-10 code
K08.9
ICD-10 code description
Disorder of teeth and supporting structures, unspecified
Primary outcomes
1
Description
Amount of interdental papilla reconstruction
Timepoint
3 months and 6 monthes after intervention
Method of measurement
Measuring the area with Imagej software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 0,2ml Acid hyaloronic gel in the interdental papilla wich has been lost, 3 times with 2 weeks interval
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dentistry faculty
Full name of responsible person
Ali Azadikhah
Street address
NO 57, Pasdaran Ave, Moalem Squere
City
Shiraz
Province
Fars
Postal code
7185981633
Phone
+98 71 3631 9957
Email
a2.azadikhah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Andishe Tadbir
Street address
ِDentistry faculty-Ghomabad-Ghasrodaht-shiraz
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3627 0322
Email
Denth_pazho@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?