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

NCT ID: NCT06519019

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Dental Implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hydrophilic Dental Implant Group

One dental implant placed will have hydrophilic properties.

Group Type EXPERIMENTAL

Dental Implant Surgery - Hydrophilic group

Intervention Type 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

This Conventional Dental implant group will act as control.

Group Type ACTIVE_COMPARATOR

Dental Implant Surgery - Conventional group

Intervention Type 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.

Interventions

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Dental Implant Surgery - Hydrophilic group

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.

Intervention Type PROCEDURE

Dental Implant Surgery - Conventional group

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Prabhuji MLV, MDS

Role: CONTACT

9448057407 ext. 91

Swaroop Varghese M, BDS

Role: CONTACT

9207248380 ext. 91

Other Identifiers

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02_D012_147447

Identifier Type: -

Identifier Source: org_study_id

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