CTRI

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CTRI Number

CTRI/2025/07/091061 [Registered on: 17/07/2025] Trial Registered Prospectively

Last Modified On:

17/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Single Arm Study

Public Title of Study

Correlation between serum Vitamin D levels and success of dental implants.

Scientific Title of Study

Evaluation of correlation between serum Vitamin D levels and implant success of functionally loaded dental implants placed in edentulous ridges A retrospective 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	Priyadharshini B
Designation	Post Graduate student
Affiliation	Ragas Dental College and Hospital
Address	Room no 2, Department of Oral and Maxillofacial Surgery, 2/102, Ragas Dental College and Hospital, Uthandi, Chennai Room no 2, Department of Oral and Maxillofacial Surgery, 2/102, Ragas Dental College and Hospital, Uthandi, Chennai Chennai TAMIL NADU 600119 India
Phone	7810024332
Fax
Email	drpriyaa1410@gmail.com

Details of Contact Person
Scientific Query

Name	Dr B. Vikraman
Designation	Head of the Department
Affiliation	Ragas Dental College and Hospital
Address	Room no 2, Department of Oral and Maxillofacial Surgery, 2/102, Ragas Dental College and Hospital, Uthandi, Chennai Room no 2, Department of Oral and Maxillofacial Surgery, 2/102, Ragas Dental College and Hospital, Uthandi, Chennai Chennai TAMIL NADU 600119 India
Phone	9840059597
Fax
Email	vikramanvikraman@gmail.com

Details of Contact Person
Public Query

Name	Dr. Harish KM
Designation	Associate Professor and Guide
Affiliation	Ragas Dental College and Hospital
Address	Room no 2, Department of Oral and Maxillofacial Surgery, 2/102, Ragas Dental College and Hospital, Uthandi, Chennai Room no 2, Department of Oral and Maxillofacial Surgery, 2/102, Ragas Dental College and Hospital, Uthandi, Chennai Chennai TAMIL NADU 600119 India
Phone	9789941810
Fax
Email	harishh_2001@yahoo.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Priyadharshini B
Address	Room No 2, Department of Oral and Maxillofacial Surgery, 2/102, Ragas Dental College and Hospital, Uthandi, 600119
Type of Sponsor	Other [self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Priyadharshini B	Ragas Dental College and Hospital	Room no 2, Department of Oral and Maxillofacial Surgery, 2/102,Ragas Dental College and Hospital, Uthandi Chennai TAMIL NADU	7810024332 drpriyaa1410@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
The Institutional Ethics Committee, Ragas Dental College and Hospital, Uthandi, Chennai, 600119	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K084\|\|Partial loss of teeth,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	nil	nil
Intervention	Vitamin D in implant	Vitamin D levels are evaluated after immediately after functional loading of dental implant 6 months after placement of dental implants and success or failure of implant are evaluated based on radiographic assessment (IOPA) using Albretkssons criteria

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	All patients who underwent implant based rehabilitation of edentulous ridge All patients above 18 years of age were included in the study Both sexes would be included Be available for follow up examinations No history of diagnosed bone disease or medication known to affect bone metabolism Patient who are cooperative, motivated and hygiene conscious

ExclusionCriteria

Details

1) Compromised health conditions, which would affect wound healing
2) Known allergy to any of the materials used in the study
3) Lack of willingness to participate in the study
4) Patients with parafunctional habits that can overload the implant, such as bruxism and clenching
5) Patient with a history of psychiatric disorder
6) Pregnancy or lactation

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
evaluating implant success by Albrektssons criteria. Peri- implant radiolucency, pain, infection, Parethesia and implant mobility	Success of dental implant will be evaluated 6 months after functional loading.

Secondary Outcome

Outcome	TimePoints
NIL	NIL

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

N/A

Date of First Enrollment (India)

04/08/2025

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="3"
Months="0"
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

Patients with past history of implant placement will be included in this study. Implant success will be evaluated using IOPA (paralleling technique) taken 6 months after functional loading of dental implants. Implants success is evaluated based on Albrektsson’s criteria. Serum vitamin D levels are also measured and any correlation between serum vitamin D levels and implant success of functionally loaded dental implants will be evaluated.