| CTRI Number |
CTRI/2021/02/031135 [Registered on: 09/02/2021] Trial Registered Prospectively |
| Last Modified On: |
08/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to verify and compare Crestal bone levels and implant stability for dental implants when they are placed and immediately loaded in grafted and non-grafted bone- split mouth study |
|
Scientific Title of Study
|
“A Comparative Evaluation of Implant Stability and Crestal bone levels in Immediately Loaded Implants Placed in grafted versus non-grafted bone.â€- An in-vivo study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAKSHI RAWAL YADAV |
| Designation |
DOCTOR |
| Affiliation |
SGT UNIVERSITY, GURUGRAM |
| Address |
SGT UNIVERSITY,
BADLI ROAD,CHANDU,
BUDHERA
GURUGRAM
SGT UNIVERSITY,
BADLI ROAD,CHANDU,
BUDHERA
GURUGRAM
Gurgaon
HARYANA
122505
India |
| Phone |
9810155281 |
| Fax |
|
| Email |
sakshi.rwl11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NUPUR DABAS |
| Designation |
DOCTOR |
| Affiliation |
SGT UNIVERSITY, GURUGRAM |
| Address |
SGT UNIVERSITY,
BADLI ROAD,CHANDU,
BUDHERA
GURUGRAM
SGT UNIVERSITY,
BADLI ROAD,CHANDU,
BUDHERA
GURUGRAM
Gurgaon
HARYANA
122505
India |
| Phone |
9873163023 |
| Fax |
|
| Email |
drnupurdabas82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAKSHI RAWAL YADAV |
| Designation |
DOCTOR |
| Affiliation |
SGT UNIVERSITY, GURUGRAM |
| Address |
SGT UNIVERSITY,
BADLI ROAD,CHANDU,
BUDHERA
GURUGRAM
SGT UNIVERSITY,
BADLI ROAD,CHANDU,
BUDHERA
GURUGRAM
Gurgaon
HARYANA
122505
India |
| Phone |
9810155281 |
| Fax |
|
| Email |
sakshi.rwl11@gmail.com |
|
|
Source of Monetary or Material Support
|
| FACULTY OF DENTAL SCIENCES, SGT UNIVERSITY,GURUGRAM-122505 |
|
|
Primary Sponsor
|
| Name |
SAKSHI RAWAL |
| Address |
SGT UNIVERSITY
CHADU
BUDHERA
GURUGRAM 122505 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR NUPUR DABAS |
FACULTY OF DENTAL SCIENCES, SGT UNIVERSITY, GURUGRAM,HARYANA
122505 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SAKSHI RAWAL |
SGT UNIVERSITY |
FACULTY OF DENTAL SCIENCES, DEPARTMENT OF PROSTHODONTICS, ROOM NO.3
SGT UNIVERSITY,CHANDU, BUDHERA, GURUGRAM, 122505HARYANA-122505
Gurgaon
HARYANA |
9810155281
SAKSHI.RWL11@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONIONAL RESEARCH COMMITTE AND INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, (2) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PLACE COLLAGEN GRAFT POST EXTRACTION |
MPLANT STABILITY AND CRESTAL BONE LEVELS OF IMMEDIATELY LOADED IMPLANTS IN GRAFTED SITE
DURATION 1 YEAR |
| Comparator Agent |
SPONTANEOUS HEALING OF SOCKET |
IMPLANT STABILITY AND CRESTAL BONE LEVELS TO BE EVALUATED AND COMPARED IN BOTH GRAFTED AND NON-GRAFTED SITE
DURATION 1 YEAR |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having grossly decayed or grade III mobile mandibular posterior teeth indicated for extraction and willing for tooth replacement, without any acute exudate/pus.
2. Patients having minimum available alveolar bone height of 3-4 mm present apically from the base of the extraction socket at the restorative site.
3. Patients having minimum available inter occlusal space of 8-10 mm at the restorative site.

4. Patients with good oral hygiene.

5. Patients who do not have any known systemic disease.
 |
|
| ExclusionCriteria |
| Details |
1 .According to ASA Classification Class 4 patients

Organic heart disease with marked signs of cardiac insufficiency.

Recent myocardial infarction of less than 6 months duration.

Unstable angina.

Patients with advanced degrees of pulmonary, renal or endocrine insufficiency.

2 .According to ASA Classification Class 3 patients
Uncontrolled diabetes with complications to vascular or other organs, i.e., retinopathy, neu- ropathy, etc.

3. Immunocompromised patients.
4. Blood dyscrasias
5. Occlusal anomalies
Deep Bite Cross Bite
6. Para-functional Habits
•
7. Heavy smokers (more than 10 cigarettes per day).
 8. Alcohol abusers.

9. Recent history of any acute illness .

• • • •
• •
•
Bruxism
6. Radiation therapy in orofacial region

6
10. Patients having unrealistic expectations and psychological problems. 11. Local Factors :
Insufficient inter-arch space
Edentulous opposing arch (maxillary arch)

Intraoral draining sinus in relation to the proposed implant site

Perforation and/or loss of labial bony plate during extraction

Radiographically assessed jumping space greater than 2mm circumferentially

Unfavourable implant axis orientation Patients with TMJ disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPLANTS STABILITY AND CRESTAL BONE LEVELS SIMILAR FOR BOTH GRAFTED AND NON-GRAFTED SITES |
BASELINE, 1 MONTH, 3 MONTH, 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPLANT STABILITY AND CRESTAL BONE LEVELS IN IMMEDIATELY LOADED IMPLANTS ARE SIGNIFICANT FOR EACH GROUP AND NON-SIGNIGICANT WHEN COMPARED IN GRAFTED AND NON-GRAFTED SITE. |
BASELINE, 1 MONTH, 3 MONTH, 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/02/2021 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sakshi.rwl11@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study was conducted in Department of Prosthodontics, Crown and Bridge and Oral Implantology, SGT University, Gurugram. It was carried out on local patients who had grossly decayed teeth with poor prognosis, one in each quadrant in mandible. The replacement of the tooth was done with endosseous dental implants. The main aim of the study was to evaluate and compare crestal bone levels and implant stability in immediately loaded dental implants in grafted and non-grafted site. A total of 20 implants were placed in 10 patients. All the patients underwent extraction and implant placement under local anaesthesia. Post extraction, in one of the two quadrants collagen plug is used as the graft material (Test group), and the opposite site is left for spontaneous healing (Control group). After the time interval of 3 months, implants are placed in both the sites i.e grafted and non-grafted. At the time of implant placement, the implants are immediately loaded for both test and control groups. Crestal bone levels were evaluated by means of standardized RVG’s at the time of implant placement, and at time intervals of 1month,3 month,6 months respectively for both groups. Implant stability was measured to assess the level of osseointegration. OstellTM was used to measure the stability of implant at the time of implant placement, 1 month, 3 month, 6 month post-operatively. |