NCT07705399

Brief Summary

This clinical study aims to evaluate the clinical and radiographic outcomes of immediate dental implant placement in mandibular premolar sites. Patients requiring extraction of mandibular premolars will receive immediate implant placement, with or without autogenous bone grafting, according to the study protocol. When indicated, autogenous bone graft will be harvested using piezosurgery during the implant procedure. Participants will be followed up clinically and radiographically to assess implant stability, marginal bone level changes, and peri-implant tissue conditions over a defined follow-up period. The results of this study may help determine the effectiveness and predictability of immediate implant placement in mandibular premolar regions.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress80%
May 2025Nov 2026

Study Start

First participant enrolled

May 17, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2026

Expected
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

June 27, 2026

Last Update Submit

July 10, 2026

Conditions

Tooth LossPartial Edentulism in the Maxilla or in the Mandible

Keywords

Immediate implant placementDental implantsMandibular premolarsAutogenous bone graftOsseointegrationImplant stabilityMarginal bone loss

Outcome Measures

Primary Outcomes (1)

  • Osseointegration success rate (%)

    Implant success will be evaluated based on the absence of mobility, pain, infection, and peri-implant radiolucency around the implant.

    6 months after implant placement.

Secondary Outcomes (4)

  • Implant stability (ISQ)

    At implant placement and 6 months after implant placement

  • Marginal bone loss (mm)

    Baseline (at implant placement) and 4 months after implant placement

  • Implant survival rate (%)

    6 months after implant placement

  • Postoperative complication (%)

    Up to 6 months after implant placement.

Study Arms (2)

Immediate implant without bone graft

ACTIVE COMPARATOR

Immediate implant without bone graft

Procedure: Immediate implant without bone graft

Immediate implant with graft

EXPERIMENTAL

Immediate implant with outogenous bone graft

Procedure: Immediate implant with autogenous bone graft

Interventions

Immediate implant with autogenous bone graftPROCEDURE

Immediate implant with autogenous bone graft using piezo surgery

Immediate implant with graft
Immediate implant without bone graftPROCEDURE

Immediate implant without bone graft

Immediate implant without bone graft

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients requiring extraction of mandibular premolars.
  • Age ≥ 25 years.
  • Adequate oral hygiene and motivated patients for implant treatment.
  • Sufficient bone volume to allow immediate implant placement (with or without minor augmentation).
  • Patients willing to participate and attend follow-up visits for at least 6 months.
  • Systemically healthy patients (ASA I or II).

You may not qualify if:

  • Uncontrolled systemic diseases (e.g., uncontrolled diabetes, immunocompromised patients).
  • Heavy smokers (e.g., \>10-15 cigarettes/day).
  • Active periodontal or acute infection at the implant site.
  • Poor oral hygiene or non-compliant patients.
  • Pregnancy or lactation.
  • History of radiotherapy in head and neck region.
  • Severe bone deficiency not suitable for immediate implant placement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University, Faculty of Dentistry

Ismailia, 4312, Egypt

Location

MeSH Terms

Conditions

Tooth Loss

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2026

First Posted

July 15, 2026

Study Start

May 17, 2025

Primary Completion

July 17, 2026

Study Completion (Estimated)

November 20, 2026

Last Updated

July 15, 2026

Record last verified: 2026-07

Locations

EG(1)