To evaluate and compare immediate implant placement along with provisionalization with and without Concentrated Growth Factor-enriched bone graft

Phase 3

Completed

Conditions: Other external cause status, (2) ICD-10 Condition: Y998||Other external cause status,

Registration Number: CTRI/2021/01/030848

Lead Sponsor: Dr Vinisha Bajaj

Brief Summary: This is a Randomized Controlled clinical and radiographic trial designedto evaluate and compare the effect of immediate implant placement with provisionalization with and without CGF enrichedbone graft on hard and soft tissues in the peri implant area

Total 30 sites fulfilling the inclusion criteria inmaxillary anterior aesthetic area visiting the department of Periodontics andImplant Dentistry at VSPM Dental College and Research Centre Nagpur will beincluded in the study

Immediate implants with provisionalization will beplaced

The study population will be divided into 2 groups

**GROUPI** Immediate implant placement withprovisionalization without CGF enriched bone graft

**GROUPII** Immediate implant placement withprovisionalization with CGF enriched bone graft

The primary outcome will be assessment of hard &soft tissue changes after immediate implant placementclinically at baseline 3 and 6 months and radiographically using CBCT atbaseline and 6 months

The secondary outcome will be soft tissue assessment withTestori implant esthetic score

Bleeding on probing

Probing depth

Patientsatisfaction using VAS scale

The briefdescription of entire procedure will be given to every patient before startingthe procedure

Writteninformed consent will be obtained from the patients

**Clinicalparameters**

1 Mombelliâ€™s modified Plaque index (mPI)

2 Mombelliâ€™s modified sulcular bleeding index (mSBI)

3 Probing pocket depth (PPD)

4 Soft Tissue Assessment

5 Ridge Width Measurement

**RadiographicParameters**

1 Crestal bone height

2 Buccal bone thickness

3 Ridge width

4 Vertical Distance

5 Jumping Gap

6 Measuring the radiolucent area between shoulder of implant andbone crest

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

INCLUSION CRITERIA 1 Systemically healthy patients 2 Patient with healthy and stable soft tissue architecture 3 Sites at which minimum torque of 35 Ncm is obtained at the time of implant insertion 4 Co-operative motivated and hygiene conscious patients 5 Tooth/teeth with Grade I or II mobility required to be extracted 6 Root stumps 7 Tooth with endodontic failure or non-restorable caries or vertical fracture.

Exclusion Criteria

EXCLUSION CRITERIA 1 General contraindications to implant surgery 2 Patients with a history of irradiation in the head and neck area within the last 6 months 3 Treated or under treatment with intravenous amino-bisphosphonates 4 Smokers or patients with poor oral hygiene 5 Patients with para-functional habits 6 Pregnant or lactating females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hard and soft tissue changes clinically at baseline 3 & 6 months and radiographically using CBCT at baseline & 6 months post operatively	baseline 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Soft tissue assessment with Testori Implant Esthetic Score	Bleeding on probing

Trial Locations

Locations (1): 1 VSPM Dental College and Research Centre Nagpur 2 TRUESCAN Dental Diagnostics
🇮🇳
Nagpur, MAHARASHTRA, India
1 VSPM Dental College and Research Centre Nagpur 2 TRUESCAN Dental Diagnostics
🇮🇳Nagpur, MAHARASHTRA, India
Dr Vinisha Bajaj
Principal investigator
9284088553
itsvinisha@gmail.com