CTRI

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CTRI Number

CTRI/2023/01/048793 [Registered on: 06/01/2023] Trial Registered Prospectively

Last Modified On:

04/01/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Gum Esthetics with Intermediate Screw on Implant

Scientific Title of Study

Evaluation of Peri-implant Bone Loss and Soft Tissue Conditioning After Immediate Implant Placement Using Conventional vs CAD/CAM Custom-Made Healing Abutment- A Randomized Controlled Clinical

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Krishna Thakkar
Designation	Post Graduate Student
Affiliation	Narsinhbhai Patel Dental College and Hospital
Address	Room 3, Department of Prosthodontics and Crown and Bridge, Ground Floor, Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Nr. Kamana Circle, Visnagar, 384315 Room 3, Department of Prosthodontics and Crown and Bridge, Ground Floor, Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Nr. Kamana Circle, Visnagar, 384315 Mahesana GUJARAT 384315 India
Phone	9913214355
Fax
Email	krishu995.kt@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sareen Duseja
Designation	Professor
Affiliation	Narsinhbhai Patel Dental College and Hospital
Address	Room 3, Department of Prosthodontics and Crown and Bridge, Ground Floor, Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Nr. Kamana Circle, Visnagar, 384315 Room 3, Department of Prosthodontics and Crown and Bridge, Ground Floor, Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Nr. Kamana Circle, Visnagar, 384315 Mahesana GUJARAT 384315 India
Phone	9979961730
Fax
Email	drsareenduseja@gmail.com

Details of Contact Person
Public Query

Name	Dr Krishna Thakkar
Designation	Post Graduate Student
Affiliation	Narsinhbhai Patel Dental College and Hospital
Address	Room 3, Department of Prosthodontics and Crown and Bridge, Ground Floor, Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Nr. Kamana Circle, Visnagar, 384315 Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Nr. Kamana Circle, Visnagar, 384315 Mahesana GUJARAT 384315 India
Phone	9913214355
Fax
Email	krishu995.kt@gmail.com

Source of Monetary or Material Support

Narsinhbhai Patel Dental College and Hospital Sankalchand Patel University Nr. Kamana Circle Visnagar- 384315

Primary Sponsor

Name	Dr Krishna Thakkar
Address	Narsinhbhai Patel Dental College and Hospital Sankalchand Patel University Nr. Kamana Circle Visnagar
Type of Sponsor	Other [Other]

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 Krishna Thakkar	Narsinhbhai Patel Dental College and Hospital	Department of Prosthodontics and Crown & Bridge Room no. 3 Sankalchand Patel University Nr. Kamana Circle Visnagar Mahesana GUJARAT	9913214355 krishu995.kt@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Narsinhbhai Patel Dental CollegeVisnagar	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Requiring replacement of teeth with implant in anterior region of jaw. Volunteers without any systemic disease which could impair wound healing

Intervention / Comparator Agent

Type	Name	Details
Intervention	soft tissue conditioning and bone remodeling with CAD/CAM Custom made healing abutment fabricated from PEEK (Polyether ether ketone)	It is patient specific fabricated for each patient falling under this group (fabrication takes 2 days) and abutment will be placed intraorally for 6 months i.e throughout the healing period)
Comparator Agent	Soft tissue conditioning and bone remodeling with conventional healing abutment	commercially available conventional titanium healing abutments

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Immediate implant placement in anterior region of jaw including premolars Patients in good general health without chronic systemic diseases with no need of additional bone and soft tissue augmentation procedures

ExclusionCriteria

Details

Acute infection at implant site/extraction socket
Dehiscence or fenestration in residual bony walls after tooth extraction
Heavy smokers (>10 cigarettes/day)
Alcohol/drug abuse and oral parafunctional habits (bruxism)
Patients who suffer from any systemic diseases that could negatively influence wound healing
Patient age <18 years
Poor oral hygiene (Full Mouth Plaque Score & Full Mouth Plaque Score >25%)
Recent Chemotherapy

Method of Generating Random Sequence

Random Number Table

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Primary Outcome

Outcome	TimePoints
Gingival health, soft tissue contour and marginal bone loss evaluated by the means of Full Mouth Bleeding Score, Full Mouth Plaque Score, Pink Esthetic Score and Functional Implant Prosthodontic Score	Soft tissue healing and bone remodelling at baseline before extraction , and 6 months after implant placement

Secondary Outcome

Outcome	TimePoints
Gingival health, soft tissue contour and marginal bone loss evaluated by the means of Full Mouth Bleeding Score, Full Mouth Plaque Score, Pink Esthetic Score and Functional Implant Prosthodontic Score	Soft tissue healing at 6 months with custom-made and conventional healing abutment

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

01/02/2023

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="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Not Applicable

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This study, a randomized controlled clinical trial would be conducted to compare and evaluate marginal bone loss and soft tissue conditioning after immediate implant placement with the use of conventional and CAD-CAM custom- made healing abutment fabricated from PEEK.

For the purpose of this study 40 patients are to be selected that require immediate implant placement in fresh extraction socket in the anterior region of jaw (including premolars) provided they sign an informed consent and satisfy the inclusion criteria. These patients will then be randomly divided based on table of random numbers into two groups. The group â€“ A patients will receive conventional healing abutment whereas, Group- B patients will receive custom-made healing abutment. Indices FMBS and FMPS would be recorded prior to the surgical phase and PES to be recorded based on Pre-operative photograph. After the completion of healing period Indices will again be recorded 1 week post prosthesis insertion. FMBS, FMPS alongwith the FIPS would be recorded clinically, whereas; the PES would be recorded from the post- operative photographs.

The scores obtained from baseline data and after 6 months would then be statistically analyzed using paired sample t-test and independent sample t-test alongwith one-way ANOVA for intragroup and intergroup comparison.