Clinical Study of Implants With Modified Surface Treatment

January 9, 2026 updated by: SmileDent Kft.

The observed medical device in this study were SGS P7D Dental implant. The device replaces the lost tooth root, and provides support for the dental bridges and crowns, or overdenture replacements. This medical device provides the opportunity to to replace partial or complete missing teeth. Device material: Ti-6Al-4V Device surface protection: Corundum Blasting and

  1. phosphate surface treatment or
  2. hydroxylapatite surface treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective, randomized, two-arms "split-mouth" study. The two arms: right and left of the same mandible of the same volunteer with a different surface treatment, but every other circumstances of the implants are the same, the same device with different surface materilas.

"A" treatment: Implant with phosphate surface treatment is the lower one in the right side of the jawbone, with hydroxylapatite surface treatment implant is placed in the left side of the lower jaw. "B" treatment: Implant with phosphate surface treatment in the lower jaw on the left side, the bottom is an implant with hydroxylapatite surface treatment is inserted into the right side of the jaw bone

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Szeged, Hungary, 6724
        • SmileDent Kft.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • complete lack of teeth in the lower jaw
  • decision of the investigator: the patient is appropriate for implantation, clinical conditions are sufficient (adequate soft tissue and bone conditions and occlusal position;)
  • the patient's consciousness is clear, understand the planned intervention.
  • the patient communicates well with the examiner and is able to understand and comply with the requirements of the test plan.
  • witten informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Women of childbearing potential, unless she uses effective birth control until the completion of the final radiological examination, and for another 4 weeks after that.
  • A disease (including, but not limited to metabolic, hematological, kidney, liver, lung, neurological, endocrine, cardiac, infectious and gastrointestinal disease), which -in the opinion of the investigator- significantly affects the health of the examined person and/or exposes to an unacceptably high risk the person receiving the implantation treatment.
  • Malignant disease in the medical history in the preceding 24 months.
  • Known HIV, hepatitis B or hepatitis C, or any other considered viral infection relevant by the examiner known at the tome of randomization
  • A medical or psychiatric illness which, in the opinion of the investigator, excludes that the participant adheres to the protocol, or complete the study according to the protocol.
  • Participation in an other interventional clinical study within 6 months prior to treatment.
  • Known allergy to the implant or to the invetigational template or any of its components.
  • Limitation of mouth opening, which make unpossible to complete the procedure, based on the opinion of the investigator
  • Increased pharyngeal reflex, reduced ability to tolerate intraoral manipulation
  • Radiotherapy, previous irradiation of the jawbones
  • INR > 2.5
  • Immunosuppressed patient
  • previous or current bisphosphonate treatment
  • Known alcohol or drug abuse
  • Heavy smoking (≥ 20 cigarettes per day, or another form of smoking, used in an equivalent amount)
  • Untreated periodontitis
  • Local infection of the implant in the planned area
  • Lack of dental hygiene, e.g. not removed radixes, plaque and calculus, or radiologically detectable potential periapical focus (also in asymptomatic case )
  • Insufficient or poor oral hygiene
  • Transient infectious state, with or without fever

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (study implant on the right side)
Implant with phosphate surface device in the right side of the lower jawbone, and the hydroxylapatite surface treatment implant is placed in the left side of the lower jaw.
Device: dental implant
Dental implant surgery in the lower jawbone.
Experimental: Group B (study implant on the left side)
Implant with phosphate surface device for the lower jaw on the left side, and the implant with hydroxylapatite surface treatment is inserted into the right side of the jawbone.
Device: dental implant
Dental implant surgery in the lower jawbone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of OSSTELL ISQ score (for the degree of osseointegration indicator)
Time Frame: 36 months

Evaluation the difference between the two types surface treated implants osseointegration. For the measure is used the OSSTELL ISQ score.

results with the OSSTELL radio frequency device based on measurable stability values. Values can vary form 1-100, higher values mean better stability.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone resorption measured mesially and distally in millimeters
Time Frame: 36 months
Determining the long-term difference between different implants in relation to bone erosion around the implant (radiological based on measurements).
36 months
Volunteer-Quality of Life (OHIP Scale Scores)
Time Frame: 36 months
Establishing the effect of implantation and subsequent prosthetic intervention on the volunteers long-term quality of life based on the scales of the OHIP questionnaire (surface treatment-independent). long-term quality of life based on the scales of the OHIP questionnaire (surface treatment-independent). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse and lower scores indicate better OHRQol
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SmileDent Kft.

Collaborators

S.G.S International Kft.

Investigators

  • Principal Investigator: Márk Antal, Dr. habil., Szeged University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2019

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM-SGS_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe