| CTRI Number |
CTRI/2025/09/094383 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of post treatment outcome of short implants vs standard implants in upper back jaw |
|
Scientific Title of Study
|
Comparison of surgical outcomes between short vs standard length implants in posterior maxilla edentulous sites: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ZUBAIDA KT |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOTTAYAM |
| Address |
Room No:802
Department of Periodontics
Government dental college
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
8156952262 |
| Fax |
|
| Email |
zubikt2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BAIJU RM |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOTTAYAM |
| Address |
Room No:802
Department of Periodontics
Government dental college
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
9447279605 |
| Fax |
|
| Email |
baijurm2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ZUBAIDA KT |
| Designation |
Junior resident |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOTTAYAM |
| Address |
Room No:802
Department of Periodontics
Government dental college
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
8156952262 |
| Fax |
|
| Email |
zubikt2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics Room no.802 Government Dental College Kottayam ,kerala,india,PIN 686008 |
|
|
Primary Sponsor
|
| Name |
Zubaida K T |
| Address |
Room no 802
Department of periodontics
Government dental college,kottayam
pin:686008 |
| Type of Sponsor |
Other [Self] |
|
|
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 ZUBAIDA K T |
Government Dental College , Kottayam |
Room no. 802
Department of Periodontics,
Kottayam
KERALA |
8156952262
zubikt2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the institutional ethics committee (IEC)/Institutional review board (IRB) |
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 |
short dental implant |
short implant of size (less than or equal to 7mm) will be placed in edentulous posterior maxilla sites. |
| Comparator Agent |
standard length implant |
Standard length implant placement (more than 8 mm length) will be done .
Full-thickness mucoperiosteal flap will be raised. Osteotomy Preparation will be done with Osseodensification. For the primary stability assessment, a torque wrench reading will be obtained. Cover screw will be placed. Either 4-0 or 5-0 sutures will be used for primary closure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Single or multiple posterior maxillary edentulous sites with 6-7 mm residual bone height.
2.Patients with good systemic health.
3.Adequate bone width for implant placement - minimum 6mm at the crest.
4.No contraindications for implant surgery.
|
|
| ExclusionCriteria |
| Details |
1.Patients requiring direct sinus lift.
2.Heavy smokers or alcoholics.
3.Patients with active infections or severe periodontal disease.
4.History of head and neck radiation therapy.
5.Use of medications affecting periodontal health (e.g., bisphosphonates)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immediate Primary stability |
0 day (Baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| marginal bone level |
3rd month |
| procedure time |
0 |
| VAS |
3rd day
7th day |
| healing index |
7th day |
| OHIP 14 |
0,6 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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)
|
Open to Recruitment |
| 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
|
To
compare the immediate primary stability between short dental implants [< =7mm]
and standard-length implant[>=8mm] placed with indirect sinus lift by osseodensification
in the posterior maxilla edentulous sites using resonance frequency analyser
(Ostell device).also to compare marginal bone level, Patient related outcomes |