CTRI Number |
CTRI/2017/11/010591 [Registered on: 22/11/2017] Trial Registered Retrospectively |
Last Modified On: |
26/10/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To check the amount of bone growth by using artificial bone material with and without Hyaluronic acid gel in patients with severe gum disease. |
Scientific Title of Study
|
Clinical and Radiographic Evaluation of Hyaluronan-Nano Hydroxyapatite Composite Graft in the Regeneration of Infrabony Defects in Chronic Periodontitis Patients |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Eeshita Bhowmik |
Designation |
Post graduate student |
Affiliation |
JSS Dental College and Hospital |
Address |
Room No-9, Dept. of Periodontology, JSS Dental College and Hospital
Bannimantap
Mysore KARNATAKA 570015 India |
Phone |
7829916764 |
Fax |
|
Email |
dr.eeshita@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Deepika PC |
Designation |
Professor |
Affiliation |
JSS Dental College and Hospital |
Address |
Room No-9, Dept. of Periodontology, JSS Dental College and Hospital
Bannimantap
Mysore KARNATAKA 570015 India |
Phone |
9902066073 |
Fax |
|
Email |
deepikamysore@yahoo.co.uk |
|
Details of Contact Person Public Query
|
Name |
Eeshita Bhowmik |
Designation |
Post graduate student |
Affiliation |
JSS Dental College and Hospital |
Address |
Room No-9, Dept. of Periodontology, JSS Dental College and Hospital
Bannimantap
Mysore KARNATAKA 570015 India |
Phone |
7829916764 |
Fax |
|
Email |
dr.eeshita@gmail.com |
|
Source of Monetary or Material Support
|
Eeshita Bhowmik
Room no 9
Dept of Periodontology
JSS Dental College and Hospital
Mysuru-570015 |
|
Primary Sponsor
|
Name |
Eeshita Bhowmik |
Address |
Room no 9
Department of Periodontology
JSS Dental College and Hospital
Bannimantap
Mysuru - 570015 |
Type of Sponsor |
Other [Self sponsored] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Eeshita Bhowmik |
JSS Dental College and Hospital |
Room No-9, Dept. of Periodontology, JSS Dental College and Hospital
Bannimantap Mysore KARNATAKA |
7829916764
dr.eeshita@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Commitee JSS Dental College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Chronic Periodontitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Hyaluronic acid combined with Nano-hydroxyapatite bone graft |
commercially available Hyaluronic acid gel combined with commercially available Nano-hydroxyapatite bone graft |
Comparator Agent |
Nano-Hydroxyapatite bone graft |
commercially available |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
1. Systemically healthy male and female patients in the age range of 30-55 years having chronic generalised periodontitis.
2. Patients with contralateral intrabony pockets measuring more than or equal to 6mm.
3. Patients with radiographic evidence of bilateral vertical/angular defects.
4. Consenting patients who are cooperative and ready for regular follow up.
|
|
ExclusionCriteria |
Details |
1. Patients on antibiotic therapy in the previous six months.
2. Patients who have undergone any periodontal therapy in past 6 months.
3. Smokers
4. Pregnant /lactating women.
5. Patients who are medically compromised or under therapeutic regimen that may alter the probability of soft tissue and bone healing.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
efficacy of Hyaluronan-Nano hydroxyapatite composite graft in comparison with Nano hydroxyapatite graft alone, in the treatment of infrabony defects. |
12 month period (3,6,9,12 month) |
|
Secondary Outcome
|
Outcome |
TimePoints |
to evaluate Clinical Parameters and Bone fill |
3,6,9,12 months |
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
|
27/07/2017 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Periodontitis is an inflammatory
disease of the supporting tissues of the teeth caused by specific
microorganisms or groups of specific microorganisms, resulting in progressive
destruction of the periodontal ligament and alveolar bone with pocket formation,
recession or both. 1
Periodontal therapy aims primarily at
the arrest of progression of disease, along with formation of new bone,
cementum and periodontal ligament (PDL). 2
Various types of bone grafts have been
used along with conventional surgical procedures for regeneration of bone and
PDL.3 Hydroxyapatite, having a biomimetic property of replicating
the native mineral content of bone tissue, is most commonly used. It is osteophilic
and osteoconductive. Osteoconductive materials neither inhibit nor induce bone
formation. They only act as a scaffold for bone formation.4
Hyaluronan or Hyaluronic acid, an
important component of extra cellular matrix, on the other hand, has a
stimulatory effect on osteoblasts. Thus
it imparts osteogenic and osteoconductive properties to bone graft, when added
to it. It also acts as a connective tissue
scaffold allowing cell growth and regeneration of bone.5
Hence an attempt is being made in this
study to combine the properties of both the above materials for regeneration of
bone.
As per our knowledge there are very
sparse studies evaluating the efficacy of hyaluronan and bone graft together.
Thus, in this study, an attempt is made to evaluate the regenerative property
of hyaluronan in combination with Nano-hydroxyapatite bone graft in comparison
with Nano-hydroxyapatite bone graft alone, in the surgical management of
infrabony defects, in patients with chronic periodontitis.
|