NCT07709676

Brief Summary

This randomized controlled trial evaluated whether grafting the peri-implant "jumping gap" with injectable β-tricalcium phosphate (β-TCP) improves outcomes after immediate implant placement in sites where the horizontal gap between the implant surface and the surrounding socket wall exceeds 2 mm. Sixteen patients (a total of 39 immediate implants in the maxillary anterior and premolar regions) were randomly allocated in a 1:1 ratio to a test group (peri-implant gap filled with injectable β-TCP) or a control group (no grafting). The patient was the unit of analysis. The primary outcome was implant stability, measured by resonance frequency analysis and expressed as the implant stability quotient (ISQ) at baseline, 3 months, and 6 months. The secondary outcome was peri-implant bone density, monitored on standardized digital periapical radiographs (baseline, 3, and 6 months) and quantified at 6 months by a single cone-beam computed tomography (CBCT) scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

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

December 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 12, 2026

Last Update Submit

July 12, 2026

Conditions

Tooth Loss in the Anterior MaxillaAlveolar Bone Loss* / Therapy

Keywords

Immediate dental implantBeta-tricalcium phosphateBone graftOsseointegrationImplant stability

Outcome Measures

Primary Outcomes (1)

  • Implant stability (implant stability quotient, ISQ)

    Implant stability measured by resonance frequency analysis and expressed as the ISQ (unitless, 1-100; higher = more stable). The patient was the unit of analysis; for patients with more than one implant, the mean ISQ of that patient's implants was used.

    Baseline (immediately postoperative), 3 months, and 6 months

Secondary Outcomes (3)

  • Peri-implant bone density on periapical radiographs (Digora grayscale)

    Baseline, 3 months, and 6 months

  • Peri-implant radiodensity on 6-month cone-beam CT (HU-equivalent)

    6 month

  • Implant survival

    6 months

Study Arms (2)

control; no grafting

NO INTERVENTION

Immediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with no grafting of the peri-implant gap.

Test: beta-tricalcium phosphate grafting

EXPERIMENTAL

Immediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with the gap filled with injectable β-tricalcium phosphate (β-TCP) after implant placement.

Device: Experimental: Test: beta-tricalcium phosphate grafting

Interventions

Experimental: Test: beta-tricalcium phosphate graftingDEVICE

A β-tricalcium phosphate synthetic bone substitute supplied ready-to-use in a putty carrier (Bonegraft Biomaterials Co., Ltd., Daegu, South Korea), placed into the peri-implant jumping gap (greater th

Test: beta-tricalcium phosphate grafting

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20 to 50 years
  • Non-restorable maxillary anterior or premolar tooth requiring extraction and immediate implant placement
  • Peri-implant jumping gap greater than 2 mm at the implant site
  • Adequate inter-arch space
  • Good patient compliance

You may not qualify if:

  • Systemic disease affecting healing
  • Smoking of more than 10 cigarettes per day
  • Parafunctional habits
  • Poor oral hygiene
  • Active periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
minia university

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 16, 2026

Study Start

December 1, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)