| CTRI Number |
CTRI/2025/10/096583 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Bone Healing in Dental Implants: Early vs. Delayed Loading with Different Implant Sizes |
|
Scientific Title of Study
|
Assessment of marginal bone response in early and delayed loading protocols with different implant diameters-an in vivo comparative study utilising digital radiographic imaging technology |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMEEM PAIKKATT |
| Designation |
Post graduate student |
| Affiliation |
student |
| Address |
KMCT Dental college
A-Block
department of prosthodontics crown and bridge
1st floor
mukkam,manassery
KMCT Dental college
A-Block
department of prosthodontics crown and bridge
1st floor
mukkam,manassery
Kozhikode
KERALA
673602
India |
| Phone |
9066367374 |
| Fax |
|
| Email |
sameempaikkatt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Swapna c |
| Designation |
Proffesor |
| Affiliation |
KMCT dental college |
| Address |
KMCT Dental college
department of prosthodontics,
mukkam,manassery
KMCT dental College, Mukkam, Manassery, Kerala 673602
Kozhikode
KERALA
673602
India |
| Phone |
9447218893 |
| Fax |
|
| Email |
drswapnabhavana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAMEEM PAIKKATT |
| Designation |
Post graduate student |
| Affiliation |
KMCT dental college |
| Address |
KMCT Dental college
mukkam,manassery
KMCT Medical College Campus, Mukkam, Manassery, Kerala 673602
Kozhikode
KERALA
673602
India |
| Phone |
9066367374 |
| Fax |
|
| Email |
sameempaikkatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMCT Dental college
A-Block
department of prosthodontics crown and bridge
1st floor
mukkam,manassery |
|
|
Primary Sponsor
|
| Name |
sameem paikkatt |
| Address |
Paikkatt house
nadapuram post
kozhikode
673504 pin |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSwapna c |
KMCT dental college |
KMCT Medical College Campus Mukkam
Manassery
Kerala
673602
Kozhikode
KERALA |
9447218893
drswapnabhavana@gmail.com |
| SAMEEM PAIKKATT |
KMCT dental college |
KMCT Dental college
A-Block
department of prosthodontics crown and bridge
1st floor
mukkam,manassery
Kozhikode
KERALA |
09066367374
sameempaikkatt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Free from any systemic disease.
2.Age limits 18 to 65 of both sexes.
3.Mandibular posterior region with minimum 1.5 mm bone around the implants as per conventional implant placement.
4.Healthy periodontium.
5.Good oral hygiene |
|
| ExclusionCriteria |
| Details |
1.Patients with parafunctional habits.
2.Patients with abnormal ridge relationships.
3.Any unsatisfied bone loss at the time placement.
4.Patients underwent head and neck radiation treatment.
5.Smokers, pregnant, or lactating females.
6.Patients with unacceptable oral hygiene. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The rationale behind this study is to compare marginal bone responses in early and delayed loading protocols with various implant diameters using radiographic imaging technology, with a 6-month follow-up, to provide evidence-based guidance and to improve patient outcomes and treatment efficacy in implant dentistry. |
The rationale behind this study is to compare marginal bone responses in early and delayed loading protocols with various implant diameters using radiographic imaging technology, with a 6-month follow-up, to provide evidence-based guidance and to improve patient outcomes and treatment efficacy in implant dentistry. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
02/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to evaluate and compare the marginal bone changes when implants of different diameters are loaded by early and delayed loading protocols, using radiographic imaging technology, with a 6-month follow-up |