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A Pilot Study to compare the Clinical Effectiveness of Dental Implant made in India with a Standard Benchmarked Implant

A Pilot Study to Evaluate the Clinical Efficacy of Indigenously Designed and Manufactured Titanium Dental Implant System with Hybrid Threads and Anti-rotational Features

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051641
Enrollment
20
Registered
2023-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z458- Encounter for adjustment and management of other implanted devices

Interventions

Intervention1: Ti6Al4V based three-piece dental implant system: Duration of intervention is 1 year Control Intervention1: Straumann bone level tapered implant: Duration is for 1 year

Sponsors

Translational Center of Excellence on Biomaterials for Orthopedic and Dental Applications
Lead Sponsor
TATA Steel New Materials Business
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Absence of mandibular first molar unilaterally. Bounded edentulous space with natural teeth with minimum period of 4 months after extraction. More than 2 mm thickness of keratinised tissue around planned edentulous site. Presence of opposing natural dentition with normal occlusion. Presence of adequate bone around implant and vital structure. Good to fair oral hygiene

Exclusion criteria

Exclusion criteria: No systemic disease Presence of any local risk factor like insufficient crown space or infected site History of smoking Bruxism and other parafunctional oral habits Lactating and pregnant women

Design outcomes

Primary

MeasureTime frame
mean crestal bone lossTimepoint: Baseline, 4 and 12 months

Secondary

MeasureTime frame
Longevity of restoration and technical complication. Marginal bone loss and probing depth of soft tissue. Cone beam computed tomography (CBCT) analysis to quantify hard tissue stability or loss around the crest of the coated implant. Dental implant stability by using Resonance frequency analyser.Timepoint: Four and twelve months

Countries

India

Contacts

Public ContactDr Vibha Shetty

Faculty of Dental Sciences, Ramaiah University of Applied Sciences

vibshetty6@gmail.com9845305455

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026