NCT07574710

Brief Summary

The aim of a study was to analyze the effect of implant placement depth (4 mm versus 6 mm below the mid-facial gingival margin) on marginal bone loss (MBL) around implant and implant stability during immediate implant placement after tooth extraction. Clinical trial was conducted involving 35 patients requiring immediate implant placement after tooth extraction. Implants were placed either 4 mm (control group) or 6 mm (test group) below the mid-facial gingival margin. Primary outcome was deemed to be radiographic assessment of marginal bone level from periapical radiographs. Secondary outcome was implant stability quotient registration using resonance freaquency analyzer. The null hypothesis is that there is no significant difference in peri-implant marginal bone loss between implants placed at 4 mm depth versus 6 mm depth relative to the buccal gingival margin during immediate implant placement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

3.6 years

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Keywords

dental implant

Outcome Measures

Primary Outcomes (1)

  • Marginal bone loss around dental implant

    From implant restoration delivery till 1 year follow-up

Secondary Outcomes (1)

  • Implant stability quotient

    After implant placement and after 4 months

Study Arms (2)

4 mm

ACTIVE COMPARATOR
Procedure: Implants were positioned 4 mm below the mid-facial gingival margin

6 mm

EXPERIMENTAL
Procedure: Implant was placed 6 mm below free gingival margin

Interventions

Tooth was carefully extracted and implant was placed 4 mm below free gingival margin of the extracted tooth.

4 mm

Tooth was extracted and dental implant placed 6 mm below free gingival margin of the extracted tooth.

6 mm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) age ≥ 18 years; (2) generally healthy individuals with no medical contraindications for implant surgery; (3) healthy soft tissue, indicated by bleeding on probing (BOP) \< 20% and Plaque Index (PI) \< 25%; (4) keratinized gingiva ≥ 2 mm, both buccally and lingually; (5) presence of molar or premolar in the upper or lower jaw; (6) implant primary stability ≥ 35 Ncm; (7) intact alveolar bone walls post-extraction; (8) one study implant per patient; and (9) signed informed consent with permission to utilize data for research purposes.

You may not qualify if:

  • (1) smoking (≥ 10 cigarettes/day); (2) history of uncontrolled periodontitis; (3) uncontrolled diabetes or alcoholism; (4) medications known to impair healing; and (5) implant primary stability \< 35 Ncm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 8, 2026

Study Start

February 8, 2021

Primary Completion

September 16, 2024

Study Completion

September 16, 2024

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations