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

A Comparative Study to Evaluate Implant Stability and Peri-Implant Marginal Bone Loss Around Two Different Thread and Body Designs of Implants at Specified Time Intervals - An In Vivo Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07557836
Enrollment
30
Registered
2026-04-29
Start date
2022-06-20
Completion date
2023-12-12
Last updated
2026-05-05

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

Conditions

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

Keywords

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

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.

Detailed description

Dental implants have become a widely accepted and predictable treatment modality for the rehabilitation of partially and completely edentulous patients. The long-term success of dental implants is primarily dependent on achieving and maintaining adequate implant stability and preserving peri-implant bone levels. Implant stability is influenced by several factors, including bone quality, surgical technique, and implant design. Among these, implant macro-design-particularly thread configuration and body geometry-plays a critical role in determining primary stability and stress distribution at the bone-implant interface. Implant designs vary in terms of thread pitch, depth, and number of threads, as well as body shape (straight/cylindrical versus tapered/conical). Conical implants are believed to enhance primary stability by generating compressive forces within the surrounding bone, especially in areas of low bone density. Similarly, multiple-thread configurations may increase bone-to-implant contact and improve insertion efficiency and mechanical engagement. However, the combined influence of thread design and implant body geometry on implant stability and peri-implant bone behavior remains an area requiring further clinical investigation. The present study was designed as a randomized, prospective interventional clinical trial with a parallel-group design to evaluate and compare implant stability and peri-implant marginal bone loss between two implant systems with different macro-design characteristics. A total of 30 patients requiring implant-supported restoration in the posterior mandibular region were included. Participants were randomly assigned into two groups using a computer-generated randomization method to ensure unbiased allocation. Group A received double-threaded straight-body implants, while group B received triple-threaded conical-body implants. All implant placements were performed under standardized clinical conditions using a two-stage surgical protocol. Preoperative clinical and radiographic assessments were carried out to determine bone quality, quantity, and suitability for implant placement. Implant dimensions (diameter and length) were selected based on available bone at the implant site. Primary implant stability was measured immediately after implant placement using resonance frequency analysis, which provides implant stability quotient values as an objective and non-invasive measure of stability. The same measurements were repeated at 3 months and 6 months postoperatively to evaluate changes in stability over time, reflecting the transition from primary mechanical stability to secondary biological stability during osseointegration. Peri-implant marginal bone levels were assessed using standardized intraoral periapical radiographs obtained using a paralleling technique with grid calibration. Mesial and distal bone levels were measured relative to the implant platform at baseline, 3 months, and 6 months. These measurements were used to evaluate bone remodeling and marginal bone loss during the early healing phase. All patients were followed up at regular intervals to monitor clinical healing, implant stability, and peri-implant tissue health. Postoperative care and follow-up protocols were standardized for all participants to minimize variability. Radiographic measurements were performed twice by the same examiner to ensure consistency, and intra-examiner reliability was evaluated. The primary objective of the study was to compare implant stability between the two implant designs over time. The secondary objective was to evaluate and compare peri-implant marginal bone changes associated with each implant design during early healing. The underlying hypothesis of the study was that triple-threaded conical-body implants would demonstrate superior implant stability due to enhanced mechanical engagement and compressive force distribution, while both implant designs would show comparable peri-implant bone response within clinically acceptable limits. The results of this study are expected to contribute to the existing body of clinical evidence regarding the role of implant macro-design in influencing stability and bone preservation. This information may assist clinicians in selecting appropriate implant systems based on clinical requirements, thereby improving treatment outcomes and long-term success in implant dentistry.

Interventions

DEVICEDouble-threaded straight-body dental implant

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.

DEVICETriple-threaded conical-body dental implant

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.

Sponsors

Career Postgraduate Institute of Dental Science and Hospital Lucknow
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Implant Stability QuotientBaseline (immediately after implant placement), 3 months, and 6 monthsImplant stability was measured using resonance frequency analysis and expressed as implant stability quotient values to evaluate the primary and secondary stability of dental implants.

Secondary

MeasureTime frameDescription
Peri-implant marginal bone heightBaseline, 3 months, and 6 monthsAssessment of mesial and distal marginal bone levels around the implant was performed using standardized intraoral periapical radiographs to evaluate bone changes over time.
Marginal bone loss3 months and 6 monthsMeasurement of changes in peri-implant bone height was calculated as the difference between baseline and follow-up bone levels at mesial and distal aspects.

Countries

India

Contacts

STUDY_CHAIRKaushik Pandey, MDS

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026