Comparative Clinical Study of Implant Stability and Peri-implant Bone Loss in Two Implant Designs

NCT07557836 | Completed DMC

• 1 other identifier: CPGIDSH/22/385
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study was conducted to evaluate the effect of different dental implant designs on implant stability and peri-implant bone levels during the early healing phase. Dental implants are widely used for the replacement of missing teeth, and their long-term success depends on achieving adequate primary stability and maintaining the surrounding bone. Variations in implant design, including thread configuration and body geometry, may influence the mechanical and biological behavior of implants, thereby affecting treatment outcomes. The purpose of this study was to compare two different implant designs: double-threaded straight-body implants and triple-threaded conical-body implants. A total of 30 patients requiring implant-supported restorations in the posterior mandibular region were included in the study. Participants were randomly allocated into two groups, with each group receiving one type of implant design. Implant stability was assessed using resonance frequency analysis (RFA), which provides implant stability quotient (ISQ) values as an objective measure of stability. In addition, peri-implant marginal bone levels were evaluated using standardized intraoral radiographs. These measurements were recorded at three time points: at the time of implant placement (baseline), at 3 months, and at 6 months after placement. The primary objective of the study was to determine whether implant design influences implant stability over time. The secondary objective was to evaluate and compare marginal bone loss around the implants between the two groups during the early healing period. The main research question addressed in this study was: Does the difference in implant thread design and body geometry significantly affect implant stability and peri-implant marginal bone loss during the early healing phase? It was hypothesized that implants with a conical body design and multiple thread configuration may provide higher stability due to improved bone engagement and load distribution, while maintaining comparable bone levels around the implant. The findings of this study are expected to provide clinically relevant evidence regarding the influence of implant macro-design on treatment outcomes. This may assist dental practitioners in selecting appropriate implant systems to enhance primary stability, promote successful osseointegration, and improve long-term prognosis in implant therapy.

Conditions

Implant Stability; Peri-implant Marginal Bone Loss; Partially Edentulous Patients

Keywords

Implants; Implant Stability Quotient (ISQ); Thread design; Conical implants; Marginal bone loss

Outcome Measures

Primary Outcomes (1)

• Implant Stability Quotient

  Implant stability was measured using resonance frequency analysis and expressed as implant stability quotient values to evaluate the primary and secondary stability of dental implants.

  Baseline (immediately after implant placement), 3 months, and 6 months

Secondary Outcomes (2)

• Peri-implant marginal bone height

  Baseline, 3 months, and 6 months

• Marginal bone loss

  3 months and 6 months

Study Arms (2)

Double-threaded straight-body implant group

EXPERIMENTAL

Participants in this arm received double-threaded, straight-body dental implants placed using a standardized two-stage surgical protocol. Implant stability (ISQ) and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months to evaluate clinical performance during the early healing phase.

Device: Double-threaded straight-body dental implant

Triple-threaded conical-body implant group

EXPERIMENTAL

Participants in this arm received triple-threaded, conical-body dental implants. Implant placement was carried out following the same standardized two-stage surgical protocol. Implant stability and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months.

Device: Triple-threaded conical-body dental implant

Interventions

Double-threaded straight-body dental implant DEVICE

Placement of double-threaded, straight-body dental implants (Dentium Narrow ridge (NR)- Line) made of commercially pure titanium with an SLA surface. Implants were placed using a standardized two-stage surgical protocol in the posterior mandibular region. Implant stability and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months.

Double-threaded straight-body implant group

Triple-threaded conical-body dental implant DEVICE

Placement of triple-threaded, conical-body dental implants (Make it simple (MIS) Lance+) made of commercially pure titanium with a sandblasted and acid-etched surface. Implants were placed using the same standardized two-stage surgical protocol in the posterior mandibular region. Implant stability and peri-implant marginal bone levels were evaluated at baseline, 3 months, and 6 months.

Triple-threaded conical-body implant group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and above
• Patients with missing mandibular premolars or molars requiring implant-supported restoration
• Presence of adequate bone volume and density at the implant site for proper implant placement
• Patients with good general health and no systemic conditions affecting healing
• Patients maintaining satisfactory oral hygiene
• Patients who are cooperative and able to understand the treatment procedure
• Patients willing to undergo implant surgery and attend follow-up visits
• Patients who provide written informed consent

You may not qualify if:

• Patients with active infection or pathology at the implant site
• Patients with insufficient bone quality or volume for implant placement
• Patients with systemic diseases or conditions that may impair healing
• Patients with a history of bleeding disorders or on anticoagulant therapy
• Immunocompromised or medically compromised patients
• Patients with poor oral hygiene or non-compliance
• Pregnant or lactating women
• Patients unwilling to participate or unable to provide informed consent

Sponsors & Collaborators

• Career Postgraduate Institute of Dental Science and Hospital Lucknow: lead

Study Sites (1)

Career Postgraduate Institute of Dental Science and Hospital, Lucknow, Indi

Lucknow, Uttar Pradesh, 226020, India

Location

Related Publications (2)

• Ayub FA, Sunarso S, Dewi RS. The Influence of Implant Macro-geometry in Primary Stability in Low-Density Bone: An in vitro Study. J Int Soc Prev Community Dent. 2025 Apr 30;15(2):134-143. doi: 10.4103/jispcd.jispcd_155_24. eCollection 2025 Mar-Apr.

  PMID: 40433430 BACKGROUND

• Yamaguchi Y, Shiota M, Fujii M, Shimogishi M, Munakata M. Effects of implant thread design on primary stability-a comparison between single- and double-threaded implants in an artificial bone model. Int J Implant Dent. 2020 Aug 20;6(1):42. doi: 10.1186/s40729-020-00239-1.

  PMID: 32815046 BACKGROUND

Study Officials

• Kaushik Pandey, MDS

  Career Postgraduate Institute of Dental Science and Hospital, Lucknow, India

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, the examiner responsible for radiographic measurements and statistical analysis was blinded to the group allocation to minimize measurement and assessment bias. Due to the nature of the surgical procedure and differences in implant design, blinding of participants and care providers was not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Model Details: Participants were randomly assigned into two parallel groups using a computer-generated randomization method. Group A received double-threaded straight-body implants, while Group B received triple-threaded conical-body implants. Each participant received only one type of implant, and outcomes were assessed at baseline, 3 months, and 6 months without crossover between groups.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: June 20, 2022
• Primary Completion: July 22, 2023
• Study Completion: December 12, 2023
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available starting 6 months after publication of the study and will remain available for a period of 5 years.
• Access Criteria: Access to de-identified individual participant data (IPD) and supporting documents will be provided to qualified researchers who submit a methodologically sound research proposal. Researchers will be required to state the study's purpose and demonstrate its scientific validity. Data will be limited to variables necessary to achieve the approved research objectives, including implant stability (ISQ values) and peri-implant bone measurements. Requests should be directed to the corresponding author, and access will be granted upon review and approval of the proposal. Data and supporting documents will be shared via email or a secure data-sharing platform, in compliance with institutional ethical guidelines and patient confidentiality requirements.

Locations

IN (1)