Clinical trial NCT06519019: Evaluation of Soft and Hard Tissue Healing and Implant Stability Of Hydrophilic Versus Conventional Titanium Dental Implants.
Official title: Comparative Evaluation of Soft and Hard Tissue Healing and Implant Stability Of Hydrophilic Versus Conventional Titanium Dental Implants - A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implants
Keywords: Dental Implants
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant Stability Using Resonance Frequency Analysis
timeFrame: "Baseline", "2 weeks", "1 month", "3 months"
measure: Marginal Bone Loss Using RVG and Grid.
timeFrame: "3 months"
measure: Soft tissue healing
timeFrame: "1 Week", "2 weeks", "1 month", "3 months"
Secondary outcomes:
Other outcomes:
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Study officials:
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