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

Not Applicable

Not yet recruiting

• Conditions: Dental Implants
• Interventions: Procedure: Dental Implant Surgery - Conventional group; Procedure: Dental Implant Surgery - Hydrophilic group

• Registration Number: NCT06519019
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

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.

Detailed Description

Implant stability at early stages is one of the most important factors affecting osseointegration success. Implant stability occurs as a result of mechanical engagement with the bone (primary stability), in addition to bone remodeling and regeneration (secondary stability) . Primary stability is certainly one of the fundamental criteria influencing implant success . Although there are several techniques to assess primary stability, one of the most popular digital methods is Resonance Frequency Analysis (RFA), Osstell® system (Osstell AB Stampgatan, Gotemborg, Sweden) and Periotest.® (Siemens Medical Systems Inc, Charlotte, Nc). The primary stability of implants also depends on the geometry of the implants (i.e., length, diameter, shape, and thread) besides the surgical technique, volume, and mechanical quality of local bone.

Several methods are widely used to modify the implant surface, such as sandblasting, acid etching, anodic oxidation, fluoride treatment, machining, titanium plasma spraying, and calcium phosphate coating. In dental implant, the surface treatment is used to modify the surface topography and surface energy, resulting in an improved wettability (hydrophilicity), increased cell proliferation and growth, and accelerated osseointegration process and reduced treatment duration. Hydrophilicity presents major advantages during the initial stages of wound healing and during the cascade of events that occurs during osseointegration, facilitating bone integration.

Although there are several studies which compares hydrophilic and hydrophobic implants, there are limited split mouth studies evaluating healing capacity of hydrophilic implants and hydrophobic implants.

Hence the aim of the present study is to evaluate the Marginal bone loss, healing of soft tissue, and primary and secondary implant stability of hydrophobic and hydrophilic implants in same subjects.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Dental Implant Group	Dental Implant Surgery - Conventional group	This Conventional Dental implant group will act as control.
Hydrophilic Dental Implant Group	Dental Implant Surgery - Hydrophilic group	One dental implant placed will have hydrophilic properties.

Primary Outcome Measures

Name	Time	Method
Implant Stability Using Resonance Frequency Analysis	"Baseline", "2 weeks", "1 month", "3 months"	Implant stability is measured
Marginal Bone Loss Using RVG and Grid.	"3 months"	Marginal Bone Loss Measured
Soft tissue healing	"1 Week", "2 weeks", "1 month", "3 months"	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