CTRI

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CTRI Number

CTRI/2024/04/065588 [Registered on: 12/04/2024] Trial Registered Prospectively

Last Modified On:

10/04/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A clinical study to evaluate the gum changes after placement of dental implants using different techniques by guiding equipment system

Scientific Title of Study

Assessment Of Soft Tissue Changes after Implant Placement Using Flap Vs Flapless Technique by Dynamic Navigation System- A Randomized Clinical Triall

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 Thota Saranya
Designation	Postgraduate Student
Affiliation	Vishnu Dental College
Address	Block 2, Room 7,Department of Periodontics ,Vishnu Dental College, Vishnupur ,Bhimavaram West Godavari ANDHRA PRADESH 534202 India
Phone	7036356905
Fax
Email	saranyatrendy11@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Gautami S Penmetsa
Designation	Professor and HOD
Affiliation	Vishnu Dental College
Address	Block 2, Room 7 ,Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH 534202 India
Phone	9951011618
Fax
Email	gautamipenmetsa@gmail.com

Details of Contact Person
Public Query

Name	Dr M Satyanarayana Raju
Designation	Professor
Affiliation	Vishnu Dental College
Address	Block 2, Room 7 ,Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH 534202 India
Phone	9492293809
Fax
Email	satya@vdc.edu.in

Source of Monetary or Material Support

Vishnu Dental College, Vishnupur , Bhimavaram-534202, West Godavari District

Primary Sponsor

Name	Dr Thota Saranya
Address	Block 2 Room No 7 Department Of Periodontics, Vishnu Dental College Vishnupur, Bhimavaram
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 Thota Saranya	Vishnu Dental College	Block 2, Room 7, Department Of Periodontics, Vishnu dental college, Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH	7036356905 saranyatrendy11@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Vishnu dental College	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	Flap technique of Implant placement	Implant planning will be done as per prosthetic considerations by attaching tracker to the handpiece and jaw.Tracing and registering will be done by calibration of handpiece and drill tips on calibrator jig. A mid-crestal incision will be made and sulcular incisions will be made on the medial and distal aspects of the adjacent teeth with a No.15 blade and a full thickness flap will be elevated.Implant placement will be done through navigation.Clinical evaluation will be done at 0day,3 months and 6 months.Radiographic evaluation will be done at 0day,3 months and 6 months.Patient reported outcome measures which includes preoperative expectations, overall satisfaction with the procedure will be measured at 2 weeks.
Intervention	Flapless technique of implant placement	Implant planning will be done as per prosthetic considerations by attaching tracker to the handpiece and jaw.Tracing and registering will be done by calibration of handpiece and drill tips on calibrator jig.Implant placement will be done through navigation.Clinical evaluation will be done at 0day,3 months and 6 months.Radiographic evaluation will be done at 0day,3 months and 6 months.Patient reported outcome measures which includes preoperative expectations, overall satisfaction with the procedure will be measured at 2 weeks.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Patients with healthy periodontal status 2. Edentulous mandibular posterior sites 3. Adequate bone depth and width for implant placement

ExclusionCriteria

Details

1.Patients with uncontrolled systemic diseases
2. Pregnancy or lactating women
3. Chronic smokers
4. Patients with infectious diseases (HIV, Hepatitis B or Hepatitis C)
5. Patients undergoing radiation therapy
6. Patients under bisphosphonate therapy
7.Patients under antibiotic therapy

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Case Record Numbers

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
The soft tissue changes which include Soft tissue thickness, Width of keratinised mucosa, Papillary Height measurement, Buccolingual width of alveolar ridge	The soft tissue changes which include Soft tissue thickness, Width of keratinised mucosa, Papillary Height measurement, Buccolingual width of alveolar ridge will be measured at baseline, 3 months and 6 months

Secondary Outcome

Outcome	TimePoints
1.Implant stability 2.Crestal Bone loss 3.Wound Healing Index 4.Patient reported outcome measures	1.Implant stability will be assessed at baseline and 3 months 2.Crestal Bone loss will be assessed at baseline 3 months and 6 months 3.Wound Healing Index will be assessed at 1 week 3 weeks and 1 month 4.Patient reported outcome measures will be assessed at 2 weeks

Target Sample Size

Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32"

Phase of Trial

N/A

Date of First Enrollment (India)

25/04/2024

Date of Study Completion (India)

24/12/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

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

The purpose of the present study is to evaluate the impact of the Flapless implant placement technique compared to traditional flap elevation using dynamic navigation system on soft tissue changes. In this study 32 patients will be recruited from the outpatient department of periodontology and Implantology. In the test group, Implant planning will be done as per prosthetic considerations by attaching tracker to the handpiece and jaw. Tracing and registering will be done by calibration of handpiece and drill tips on calibrator jig. Implant placement will be done through navigation. In the control group of patients, Implant planning will be done as per prosthetic considerations by attaching tracker to the handpiece and jaw. Tracing and registering will be done by calibration of handpiece and drill tips on calibrator jig. A mid-crestal incision will be made and sulcular incisions will be made on the mesial and distal aspects of the adjacent teeth with a No.15 blade, and a full thickness flap will be elevated. Implant placement will be done through navigation. The soft tissue changes which include Soft tissue thickness, Width of keratinised mucosa, Papillary Height measurement, Buccolingual width of alveolar ridge and crestal bone loss will be measured at baseline, 3 months and 6 months. Implant stability will be assessed at baseline and 3 months. Wound Healing Index will be assesses at 1 week, 3 weeks and 1 month. Patient reported outcome measures will be assessed at 2 weeks.