| CTRI Number |
CTRI/2018/02/011840 [Registered on: 12/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
14/10/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of hard tissue dimensional changes following Immediate Implant. |
|
Scientific Title of Study
|
Radiographic evaluation of alteration of peri-implant bone following immediate implant placement associated with the use of a synthetic bone substitute |
| Trial Acronym |
REOAOP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital Pune |
| Address |
Sinhgad Dental College and Hospital Vadgaon Budruk Off Sinhgad Road Pune Sinhgad Dental College and Hospital Vadgaon Budruk Off Sinhgad Road Pune
Pune MAHARASHTRA 411041 India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anupama Kaulgud |
| Designation |
PG student |
| Affiliation |
Sinhgad Dental College and Hospital Pune |
| Address |
Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune
Pune MAHARASHTRA 411041 India |
| Phone |
7774039929 |
| Fax |
|
| Email |
drakaulgud@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital Pune |
| Address |
Sinhgad Dental College and Hospital Vadgaon Budruk Off Sinhgad Road Pune Sinhgad Dental College and Hospital Vadgaon Budruk Off Sinhgad Road Pune
Pune MAHARASHTRA 411041 India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sinhgad Dental College and Hospital,
Vadagaon (Bk)., Off Sinhgad road, Pune,411041, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Sinhgad Dental College and Hospital |
| Address |
Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Nihal Devkar |
Sinhgad Dental College and Hospital, Pune |
Dept of Periodontology, Room No.4, Vadgoan (Bk)., Off Sinhgad road,
Pune 411041
Pune MAHARASHTRA |
9420481441
drdevkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sinhgad Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients who need extraction of teeth in premolar zone due to trauma, endodontic failure or non-restorable carious teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Titanium Dental Implant, calcium phosphosilicate bone graft |
Titanium dental implant placement in Maxillary and Mandibular anterior and premolar zone.Calcium phosphosilicate bone graft placed between the implant and buccal plate. Evaluation of the outcome after 6 months period. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients between the age group 20 – 45 years.
2. Patients who need extraction of teeth in the premolar zone (anteriors and premolars).
3. Indications for extraction include trauma, endodontic treatment failure, or non-restorable carious teeth.
4. Teeth with healthy periodontium.
5. Alveolar sockets with 4 wall architecture and intact labial plate.
6. Patients willing to participate and sign an informed consent.
7. Patients who are compliant.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are systemically compromised.
2. Patients having history of smoking.
3. Patient having history of bone disorder.
4. Teeth having acute periapical or periodontal pathology.
5. Pregnant and lactating females.
6. Parafunctional habits.
7. Compromised soft tissue conditions at the surgical site.
8. Extraction sockets with one or more bony walls damaged.
9.Teeth showing periapical radiolucency.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Horizontal measurement: of buccal and palatal cortical plates
b. Horizontal measurement of total bucco-lingual width of alveolar bone
c. vertical facial bone level
|
After 6 months follow-up radiograph.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2015 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After tooth extraction,resorption of the alveolar
walls has been observed. Since the buccal bone wall is predominantly composed
of bundle bone, resorption is greater in this area, whereas less resorption of
the lingual walls has been found, since they are thicker and composed of
substantial proportions of lamellar bone.1,2
On average,
a loss of about 50% of the buccal bone contour has to be expected within 3
months after extraction.2,3Various strategies like socket
preservation techniques and immediate implants have been tested to minimize the
resorption and maintain the ridge dimensions after extraction.2
The placement of the implant into the fresh extraction
socket is called as Immediate implant. The
advantages of the immediate implant includes reduced number of visits and
surgical procedures, diminishing patient morbidity, and in some cases, enable
immediate restoration.4,5,6
Despite these advantages, however, immediate implant
placement has always been a challenge for clinicians because of its
unpredictable outcome associated with implant position and soft tissue
stability.7
Studies have demonstrated that buccolingual hard
tissue resorption occurs irrespective of implant insertion.8,9Several
approaches have been suggested in order to minimize the resorption process and/or
promote better healingwith immediate implants. This includes implants with
different geometries, collagen membranes, use of various graft or filler materials
between the implant and the buccal bone wall.10
Commercially, bioactive glasses are available in
different morphologic forms. A putty form (Novabone Dental Putty)of premixed composite of bioactive calcium silicophosphate has been
made available.11
It is composed of elements naturally occurring in the body,
which signals genetic pathways to accelerate natural bone growth. This process
is defined as Osteostimulation. Osteostimulation
leads to a catalytic response that accelerates the natural healing process and
bone regeneration.NovaBone Dental
Putty is available in multiple delivery mechanisms: clamshells, syringes and ‘Cartridge
Delivery System’.It is dispensed in a pre-mixed state and can be
placed directly into the defect site from the package.
It has found its multiple clinical applications in dentistry in the
treatment of bone defects, ridge and socket preservations, and periodontal
osseous defects including furcation defects.11 Aim: To evaluate radiographic
(CBCT) outcomes of the alveolar ridge following palatal flapless Immediate
implant placement associated with the use of a synthetic bone graft placed between
the implant and inner surface of the buccal alveolar plate. Objectives: 1. To evaluate and compare the horizontal alveolar
ridge changes on facial and palatal cortical plates after placement of
immediate implant associated with synthetic bone graft. 2.
To evaluate and compare totalbucco-lingual dimensional changes
after placement of immediate implant
associated with synthetic bone graft.
3. To evaluate and compare the verticalbuccal alveolar
ridge changes after the placement of immediate implant associated with synthetic
bone graft. |