Gum Esthetics with Intermediate Screw on Implant

Not yet recruiting

Conditions: Requiring replacement of teeth with implant in anterior region of jaw. Volunteers without any systemic disease which could impair wound healing

Registration Number: CTRI/2023/01/048793

Lead Sponsor: Dr Krishna Thakkar

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Narsinhbhai Patel Dental College and Hospital
🇮🇳
Mahesana, GUJARAT, India
Narsinhbhai Patel Dental College and Hospital
🇮🇳Mahesana, GUJARAT, India
Dr Krishna Thakkar
Principal investigator
9913214355
krishu995.kt@gmail.com