Evaluation of Soft and Hard Tissue Healing and Implant Stability Of Hydrophilic Versus Conventional Titanium Dental Implants.

NCT06519019 | Not Yet Recruiting

• 1 other identifier: 02_D012_147447
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. Researchers always tried to improve design, mechanical and chemical properties of implant. Major benefit of surface modification are to improve hydrophilicity, cell to implant adhesion and cell proliferation. These modification improve osseointegration and reduce treatment duration. In this study investigators are evaluating healing capacity of hydrophilic implant compared to conventional implant.

Conditions

Dental Implants

Keywords

Dental Implants

Outcome Measures

Primary Outcomes (3)

• Implant Stability Using Resonance Frequency Analysis

  Implant stability is measured

  "Baseline", "2 weeks", "1 month", "3 months"

• Marginal Bone Loss Using RVG and Grid.

  Marginal Bone Loss Measured

  "3 months"

• Soft tissue healing

  Soft tissue healing will be assessed using Landry Turnbull and Howley Healing Index. Where soft tissue healing will be scored from 1 to 5, where score "1" indicate worse score and score "5" indicate Best score

  "1 Week", "2 weeks", "1 month", "3 months"

Study Arms (2)

Hydrophilic Dental Implant Group

EXPERIMENTAL

One dental implant placed will have hydrophilic properties.

Procedure: Dental Implant Surgery - Hydrophilic group

Conventional Dental Implant Group

ACTIVE COMPARATOR

This Conventional Dental implant group will act as control.

Procedure: Dental Implant Surgery - Conventional group

Interventions

Dental Implant Surgery - Hydrophilic group PROCEDURE

A full thickness mucoperiosteal flap was elevated, under Local anaesthesia, osteotomy sites were prepared according to manufactures instructions, and parallel pin was used to confirm position and angulation of osteotomy site. One site received a hydrophilic implant and the other site received a conventional implant. Ostell ISQ was used to measure primary stability of the dental implant. The surgical wound closure was with mattress and single interrupted sutures, using 4-0 vicryl suture.

Hydrophilic Dental Implant Group

Dental Implant Surgery - Conventional group PROCEDURE

A full thickness mucoperiosteal flap was elevated, under Local anaesthesia, osteotomy sites were prepared according to manufactures instructions, and parallel pin was used to confirm position and angulation of osteotomy site. One site received a hydrophilic implant and the other site received a conventional implant. Ostell ISQ was used to measure primary stability of the dental implant. The surgical wound closure was with mattress and single interrupted sutures, using 4-0 vicryl suture.

Conventional Dental Implant Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least above 18 years of age.
• Patients who needs replacement of two or more teeth in mandible.
• Adequate bone volume to accommodate planned dental implants.

You may not qualify if:

• General contraindication to dental implant treatment. (Uncontrolled diabetes and severe cardiovascular or infectious diseases).
• Intravenous and oral bisphosphonate therapy.
• Presence of severe, moderate or mild untreated periodontal disease.
• Unwillingness to return for the follow-up examination.
• Smokers.
• Patients who are psychologically unable to participate.
• Poor oral hygiene.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Central Study Contacts

Prabhuji MLV, MDS

CONTACT

9448057407; prabhujimlv@gmail.com

Swaroop Varghese M, BDS

CONTACT

9207248380; dr.swaroopvm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 25, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share