| CTRI Number |
CTRI/2025/06/088846 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the clinical and radiographic changes around dental implants in low density edentulous spaces |
|
Scientific Title of Study
|
Evaluation Of Hard And Soft Tissue Changes Around Dental Implants Placed In Low Density Posterior Edentulous Ridges Using Osseodensification And Roll Technique .A Clinico Radiographic Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARIPALLI SURYA AKHIL SHARMA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
GITAM DENTAL COLLEGE AND HOSPITAL |
| Address |
43-16-23,401 , 4 TH FLOOR ,LAKSHMI NIVASAM ,INDIAN BANK BUILDING ,OPP BATA SHOWROOM LANE ,RAILWAY NEW COLONY,VISAKHAPATNAM,530016
GITAM DENTAL COLLEGE AND HOSPITAL GANDHI NAGAR,RUSHIKONDA, VISAKHAPATNAM, 530045
Visakhapatnam
ANDHRA PRADESH
530016
India |
| Phone |
9963243811 |
| Fax |
|
| Email |
suryaakhil66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GIDIJALA NAVEEN VITAL KUMAR |
| Designation |
PROFESSOR DEPARTMENT OF PERIODONTICS |
| Affiliation |
GITAM DENTAL COLLEGE AND HOSPITAL |
| Address |
GITAM DENTAL COLLEGE AND HOSPITAL GANDHI NAGAR ,RUSHIKONDA VISAKHAPATNAM , 530045
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8985886906 |
| Fax |
|
| Email |
ngidijal@gitam.edu |
|
Details of Contact Person
Public Query
|
| Name |
SARIPALLI SURYA AKHIL SHARMA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
GITAM DENTAL COLLEGE AND HOSPITAL |
| Address |
43-16-23,401 , 4 TH FLOOR ,LAKSHMI NIVASAM ,INDIAN BANK BUILDING ,OPP BATA SHOWROOM LANE ,RAILWAY NEW COLONY,VISAKHAPATNAM,530016
GITAM DENTAL COLLEGE AND HOSPITAL GANDHI NAGAR ,RUSHIKONDA,
VISAKHAPATNAM , 530045
Visakhapatnam
ANDHRA PRADESH
530016
India |
| Phone |
996324811 |
| Fax |
|
| Email |
suryaakhil66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saripalli surya Akhil Sharma |
|
|
Primary Sponsor
|
| Name |
SARIPALLI SURYA AKHIL SHARMA |
| Address |
43-16-23,401,4TH FLOOR, LAKSHIMI NIVASAM,INDIAN BANK BUILDING,OPPOSITE BATA SHOWROOM LANE,RAILWAY NEW COLONY,530016 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Saripalli Surya Akhil Sharma |
43-16-23,401,4TH FLOOR, LAKSHIMI NIVASAM,INDIAN BANK BUILDING,OPPOSITE BATA SHOWROOM LANE,RAILWAY NEW COLONY,530016 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| saripalli surya akhil sharma |
GITAM dental college and hospital |
room 6 department of periodontics
Visakhapatnam
ANDHRA PRADESH |
9963243811
suryaakhil66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
implant placement using osseodensification drills |
implants placed in type 3 and type 4 bone
densah bur and roll technique
at 3 months and 6 months time interval |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with maxillary or mandibular low density posterior edentulous ridges, individuals with good oral hygiene maintenance |
|
| ExclusionCriteria |
| Details |
Pregnant women, smokers,medically compromised individuals, individuals with parafunctional habits |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate hard and soft tissue changes around dental implants placed at low density posterior single edentulous ridges using ossedensification and roll technique |
hard tissue changes evaluated at baseline 3 months 6 months
soft tissue changes evaluated at 3 and 6 months following implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate crestal bone loss around implants, to evaluate thickness of keratinised tissue around implants ,to evaluate temporal implant stability quotient using radio frequency analysis ,to evaluate insertion torque at the time of implant placement |
0 hours ,3 months,6 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental implants are widely considered for treatment of missing teeth.Osseodensification(OD) drilling has been introduced to the osteotomy sites to achieve temporally stable implants .OD is done by use od multi stepped drilling concept using uniquely designed burs that promotes lateralisation of autogenous bone into surrounding cancellous bone, improving poor bone quality.OD osteotomies evidenced 90% reduction in diameter, due to residual strain and bone spring back effect .This study seeks to clinically and radiographically assess the primary stability,crestal bone loss, ridge thickness in posterior edentulous ridges in low density bone where an implant is placed in the osteotomy site which has been prepared using osseodensification burs.this study includes individuals satisfying the inclusion criteria and providing consent for participation .The procedure will be done in a single centre |