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NCT Number: NCT06519019

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Implant Stability Using Resonance Frequency Analysis

    Time frame: "Baseline", "2 weeks", "1 month", "3 months"

    Implant stability is measured

  2. Marginal Bone Loss Using RVG and Grid.

    Time frame: "3 months"

    Marginal Bone Loss Measured

  3. Soft tissue healing

    Time frame: "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

Study contacts

Contact information is provided by the study sponsor or research team.

Prabhuji MLV, MDS

CONTACT

[email protected]

9448057407 ext. 91

Swaroop Varghese M, BDS

CONTACT

[email protected]

9207248380 ext. 91

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

Comparative Evaluation of Soft and Hard Tissue Healing and Implant Stability Of Hydrophilic Versus Conventional Titanium Dental Implants - A Randomized Clinical Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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