NCT07027904

Brief Summary

This study aims to evaluate implant stability and Width bone after placement of immediate implant and Xenograft mixed with Hyaluronic acid or with Platelet-Rich Fibrin (PRF) at posterior mandible region

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jun 2025

Status
not yet 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 Progress80%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

May 19, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

June 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

May 19, 2025

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implant secondary stability

    Method of Measurement (Using the Osstell® Device.) -Unit of Measurement (ISQ)

    6 months

Secondary Outcomes (1)

  • width bone

    immediate postoperative and at 6 months

Study Arms (2)

using xenograft as space filling material mixed with hyaluronic acid

ACTIVE COMPARATOR

the jumping space will packed using Xenograft (cur oss , Astro star) with particle size ranging from 0.25 to 1 mm and it will be mixed with hyaluronic acid

Device: Implant

xenograft (cur oss , Astro star ) mixed with Platelet-Rich Fibrin (PRF)

EXPERIMENTAL

the jumping space will packed using Xenograft (cur oss , Astro star) with particle size ranging from 0.25 to 1 mm and it will be mixed with Platelet-rich fibrin (PRF)

Device: Implant

Interventions

ImplantDEVICE

The immediate implant was placed, and the surrounding cavity was filled with xenograft bone material, along with the application of hyaluronic acid or platelet-rich fibrin (PRF) to enhance healing and bone integration.

using xenograft as space filling material mixed with hyaluronic acidxenograft (cur oss , Astro star ) mixed with Platelet-Rich Fibrin (PRF)

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years.
  • Both sexes.
  • Cooperative and likely to maintain good dental health.
  • Recent extraction multi roots.
  • There is a bone between (2 or 3) mm at lest from the apex of the root.

You may not qualify if:

  • Patients who had undergone previous extraction of all badly decayed teeth .
  • Implant placement in both healed bone and at the extraction sites in the same procedure.
  • Presence of any local or systemic factors that might contraindicate oral surgery.
  • Poor oral hygiene.
  • Conditions that complicate wound healing such as uncontrolled diabetes, smoking (10 cigarettes a day), pregnancy, a history of drug or alcohol abuse, and an inability or unwillingness to return for follow-ups after occlusal loading.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Central Study Contacts

WASIM HALABI, MSc degree candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Bachelor's Degree of Oral and Dental Medicine

Study Record Dates

First Submitted

May 19, 2025

First Posted

June 19, 2025

Study Start

June 12, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share