| CTRI Number |
CTRI/2022/05/042789 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the stability between dental implants placed with and without adding hyaluronic acid gel. |
|
Scientific Title of Study
|
Evaluation of stability, soft tissue and hard tissue changes in implants placed with and without application of hyaluronic acid gel |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr balla sowmya |
| Designation |
I MDS |
| Affiliation |
sibar institute of dental sciences |
| Address |
2nd floor,room number 8,departement of periodontology,sibar institute of dental sciences,
takkellapadu, guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9491488650 |
| Fax |
|
| Email |
ballasowmya26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Ravindranath |
| Designation |
head of the department and professor of periodontology |
| Affiliation |
sibar institute of dental sciences |
| Address |
2nd floor,room number 8,departement of periodontology,sibar institute of dental sciences,
takkellapadu, guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Ravindranath |
| Designation |
head of the department and professor of periodontology |
| Affiliation |
sibar institute of dental sciences |
| Address |
2nd floor,room number 8,departement of periodontology,sibar institute of dental sciences,
takkellapadu, guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of Dental sciences, takellapadu village, pedakakani mandal, Guntur 522509 |
|
|
Primary Sponsor
|
| Name |
Balla sowmya |
| Address |
room number 8, 2nd floor, sibar institute of dental sciences, guntur, andrapradesh, india 522509 |
| Type of Sponsor |
Other [sibar institute of dental sciences] |
|
|
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 |
| Balla Sowmya |
Sibar institute of dental sciences |
roon no 8, 2nd floor, department of periodontics
Guntur
ANDHRA PRADESH |
9491488650
ballasowmya26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Sibar institute of dental sciences guntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
isolated edentulous mandibular posterior sites |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
hyaluronic acid gel |
Application of hyaluronic acid on implant surface is done during implant placement i.e once per patient and evaluated for every 3 months till 6th month. |
| Comparator Agent |
without hyaluronic acid gel |
Implant placement is done without application of Hyaluronic acid and patient is evaluated for every 3 months till 6th month. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals in need of tooth replacement.
2. Presence of adequate keratinized mucosa in the edentulous site.
3. Apparently healthy individuals.
4.Individuals with adequate bone volume with D2 and D3 type of bone.
5. Patient who are willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Smokers
2. Individuals with parafunctional habits.
3. Pregnant and lactating women.
4. Patients taking any medication or drug that could jeopardize treatment
outcome.
5. Systemic diseases that contraindicate implant placement and surgical
procedure.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare Resonant frequency analysis (RFA) and crestal bone level (CBL) between groups |
baseline ,3months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare plaque index(PI), gingival index(GI), Width of the keratinized tissue (WKT), Thickness of keratinized tissue (TKT)
|
baseline ,3months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/05/2022 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Replacement of missing teeth with an implant in partially or fully
edentulous sites has become a preferred and realistic alternative treatment
without involving adjacent teeth. Single tooth replacement with endosseous
dental implant comprises the most widely used form with success rates of 90% to
100% in terms of implant survival and prosthetic outcomes. Implant
rehabilitation of missing tooth has been most widely opted treatment modality
for partially/completely edentulous patients who aspire long term survival and
success rates of the replaced prosthesis. However, implant success is mostly
dependent on the concept of “OSSEOINTEGRATION†proposed by Branemark in
the year 1969, which nearly takes 6 to 7 months to heal without any
intervention. Osseointegration refers to a direct structural and functional
connection between ordered, living bone and the surface of a load-carrying
implant. Currently, an implant is considered as osseointegrated
when there is no progressive relative movement between the implant and the bone
with which it has direct contact. Different
approaches have been introduced lately to positively enhance the healing around
dental implants. One approach to enhance osseointegration of dental implants is
the coating with organic components of the extracellular matrix. Hyaluronic
acid (HA) was First discovered in the vitreous humour of
the eye in 1934 and subsequently synthesized in vitro in 1964, hyaluronic acid
(or hyaluronate or hyaluronan) is a negatively charged, with high molecular
weight (up to 107 Daltons) glycosaminoglycan found predominantly in the
extracellular matrix. Hyaluronic acid possesses physiological
and structural functions in the tissues, including cellular and extracellular
interactions, interactions with growth factors and regulation of the osmotic
pressure and tissue lubrication, which helps in maintaining the tissues
structural and homeostatic integrity. Hyaluronic
acid has a multifunctional role in healing chronic lesions, including those
that are observed in periodontal disease. HA-coated
surface may possess a higher potency to enhance osteogenesis. This study is designed to evaluate the efficacy of hyaluronic acid gel
on implant stability, soft tissue and hard tissue changes when compared to
conventional implant placement
|