The aim of this study is comparison of Gingival dimensional changes around the teeth using Matrix Allogenic and Xenogenic Matrix.
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Patients referred to department of periodontics, Shahid Beheshti University of Medical Sciences; first, all patients undergo phase 1 periodontal treatment. Then, in the next stage, the surgery is done using the CAF (Coronally Advanced Flape) technique in the receptor area. The graft are placed between the teeth and the flap, then taken to the suture area. At intervals 2 to 4 weeks and then monthly one day after surgery for prophylaxis patients. At intervals of two weeks, three months, six months and one year after surgery, Clinical parameters are measured by the periodontal department Resident who was not aware of the process of research and treatment for each of the teeth.
Participants/Inclusion and exclusion criteria
Not having proper gingival thickness (less than 1 mm); good health (plaque rate based on O'Leary index below 20%); pocket depth is less than 3 mm; no smoking; no orthodontic treatments; no pregnancy; no occlusal trauma; no periodontal surgeries in the last 12 months; no severe malocclusion in the examined area; no oral mucosal diseases and no systemic diseases.
Intervention groups
Patients are divided into two groups: Allograft and Xenograft surgery.
Main outcome variables
Gingival thickness; gingival recession; keratinized gingiva width; pocket depth; clinical attachment loss; plaque Index and gingival Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190617043911N1
Registration date:2019-07-02, 1398/04/11
Registration timing:registered_while_recruiting
Last update:2019-07-02, 1398/04/11
Update count:0
Registration date
2019-07-02, 1398/04/11
Registrant information
Name
Hoda Parandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4462 3128
Email address
parandeh94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Gingival Dimensional Changes Around the Teeth Using Allogenic and Xenogenic matrix in Thin Gingiva Patients
Public title
Effect Allogenic and Xenogenic matrix in treatment of thin gingiva
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not having Proper Gingival Thickness (less than 1 mm)
Good health (Level of plaque based on the O'Leary index below 20% )
Pocket Depth less than 3 mm
Exclusion criteria:
Smoking
Orthodontic Treatments
Pregnancy
Occlusal Trauma
Periodontal Surgeries in the last 12 months
Severe Malocclusion in the examined area
Oral Mucosal diseases
Systemic disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
3
Tooth
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization, Individual, Sealed Envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
Resident of Periodontics who is not aware of the Process of Research and Treatment for each of the Teeth and Statistics specialist
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences (dental College)
Street address
Shahid Beheshti University of Medical Sciences (dental College), Daneshjoo Ave, Velenjak, Shahid Chamran Blvd, Tehran, Iran
At the Base of the study (before the intervention) and 3 weeks, 2 months, 6 months and one year after the surgery, increased Gingival Thickness with two Materils of mucoderm and Alloderm.
Method of measurement
Gingival thickness measurements using the Sperider whit Rubberpoint and digital caliper
Secondary outcomes
1
Description
En Variable: Gingival Recession, Patients who have Gingival Recession
Timepoint
At the Base of the study (before the intervention) and 3 weeks, 2 months, 6 months and one year after the surgery, increased Gingiva with two Materils of mucoderm and Alloderm
Method of measurement
Gingival Recession measurements using the digital caliper