NCT07700706

Brief Summary

This randomized clinical trial compares three peri-implant jumping gap management approaches following fully guided immediate implant placement in the maxillary esthetic zone. Clinical and digital outcomes will be evaluated after immediate provisionalization and final restoration.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 8, 2026

Last Update Submit

July 21, 2026

Conditions

Guided Immediate Implant PlacementBone GraftingCustomized Healing AbutmentProvisional CrownTooth Loss in the Esthetic Zone Requiring Immediate Implant Placement

Keywords

Immediate implant placementFully guided surgeryJumping gap managementPeri-implant defectSilicate-added β-TCP puttyExtended sticky boneBone graftingMaxillary esthetic zoneImmediate provisionalizationClinical outcomesDigital outcomesRandomized clinical trial

Outcome Measures

Primary Outcomes (2)

  • Implant Stability

    Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).

    Immediate post-operative, 3 months, and 6 months.

  • Hard Tissue (Peri-implant bone)

    Marginal bone loss will be assessed using CBCT measured in mm.

    - Immediately after implant placement - 6 months after implant placement.

Secondary Outcomes (1)

  • Soft Tissue

    Baseline, 1 month, 3 months, and 6 months.

Study Arms (3)

Control group

EXPERIMENTAL

Fully guided immediate implant placement with an ungrafted peri-implant jumping gap and immediate CAD/CAM provisionalization.

Procedure: No Grafting

Study Group 1 (Si-β-TCP Putty Group)

EXPERIMENTAL

Fully guided immediate implant placement with a peri-implant jumping gap filled using silicate-added β-TCP putty and immediate CAD/CAM provisionalization.

Procedure: Silicate-Added β-TCP Putty

Study Group 2 (Extended Sticky Bone Group)

EXPERIMENTAL

Fully guided immediate implant placement with a peri-implant jumping gap filled using extended sticky bone and immediate CAD/CAM provisionalization.

Procedure: Extended Sticky Bone

Interventions

No GraftingPROCEDURE

The peri-implant jumping gap was managed without grafting.

Control group
Silicate-Added β-TCP PuttyPROCEDURE

The peri-implant jumping gap was managed using silicate-added β-TCP putty.

Study Group 1 (Si-β-TCP Putty Group)
Extended Sticky BonePROCEDURE

The peri-implant jumping gap was managed using extended sticky bone.

Study Group 2 (Extended Sticky Bone Group)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-restorable teeth in maxillary esthetic zone requiring dental extraction.
  • Age range: from18 to 50 years.
  • Adequate inter-arch relation and inter-occlusal space to accommodate the prosthetic restoration.
  • Jumping gap more than 2mm.
  • Patients with good oral hygiene.
  • Patients willing to participate in the study's follow-up intervals.

You may not qualify if:

  • Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
  • Alcohol or drug abuse.
  • Smokers.
  • Patients with systemic diseases that absolutely contraindicate implant placement (bleeding disorders, immunosuppression,…etc.)
  • Pregnancy.
  • Patients with para-functional habits (bruxism and clenching).
  • Lack of motivation or inability to maintain good oral hygiene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

Study Design

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

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 14, 2026

Study Start

December 1, 2025

Primary Completion

June 30, 2026

Study Completion

July 1, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)