NCT07078890

Brief Summary

The aim of this study was to investigate the effect of bone augmentation simultaneous to implant removal on the prognosis of reimplantation at the same sites, providing recommendations for management strategies after failed implant removal.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Mar 2025Aug 2027

Study Start

First participant enrolled

March 12, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

July 13, 2025

Last Update Submit

July 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ridge Height (RH)

    Two reference lines were established for the radiological analysis: the longitudinal axis of the implant and a line perpendicular to this axis and tangential to a reference point (sinus floor in the maxilla and mandibular base in the mandible).Ridge height (RH) in mm, defined as the distance between the tangential reference line and the most coronal point of the bone crest, assessed buccal (B-RH) and lingual (L-RH).

    Before implant removal and 6 months after implant removal

Secondary Outcomes (8)

  • Ridge Width (RW)

    Before implant removal and 6 months after implant removal

  • Bone Plate Thickness (BPT)

    Before implant removal and 6 months after implant removal

  • Bone Mineral Density(BMD)

    6 months after implant removal

  • Inserting Torque(IT)

    Replantation surgery

  • Implant Survival Rate(SVR)

    6 months and 12 months after restoration

  • +3 more secondary outcomes

Study Arms (2)

Bone augmentation simultaneous to implant removal

EXPERIMENTAL

Placement of bone substitutes in the socket simultaneous to implant removal, and reimplantation is performed after 6 months of healing.

Procedure: bone augmentation simultaneous to implant removal

Natural healing after implant removal

NO INTERVENTION

Interventions

Placement of bone substitutes in the socket simultaneous to implant removal, and reimplantation is performed after 6 months of healing.

Bone augmentation simultaneous to implant removal

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age greater than 18 years 2. Implant failure requiring removal 3. Plan to reimplant in the same site 4. Periodontal health, or stabilized periodontitis after treatment

You may not qualify if:

  • \. Uncontrolled metabolic diseases 2. Taking medications that have an effect on bone metabolism 3. The implant has detached at the time of consultation 4. Do not consent to reimplant in the same site 5. Unwillingness to participate in the follow-up of this study 6. Other conditions that do not qualify for implant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital of Stomatology, Wuhan University

Wuhan, Hubei, 430079, China

RECRUITING

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Shanghai Stomatological Hospital

Shanghai, 200001, China

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2025

First Posted

July 22, 2025

Study Start

March 12, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations