NCT06863051

Brief Summary

The objective of this study will be to compare between Immediate Implant grafted with xenograft and Alb-PRF gel versus xenograft with L-PRF.

Trial Health

77
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
8mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
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 Progress56%
Aug 2025Feb 2027

First Submitted

Initial submission to the registry

February 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2027

Expected
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

February 27, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

ImplantPRFAlbumin

Outcome Measures

Primary Outcomes (3)

  • Vertical peri-implant bone level

    the distance between implant platform to the most coronal bone-implant contact

    Immediate Post-Operative and 6 months after surgery

  • Keratinized tissue Width

    Width of Keratinized tissue before and after surgery

    Immediate Post-Operative and 6 months after surgery

  • Crestal bone level

    distance between implant platform and bone crest

    Immediate Post-Operative and 6 months after surgery

Secondary Outcomes (2)

  • Implant Stability

    Immediate Post-Operative and 6 months after surgery

  • Bucco-lingual bone width

    Immediate Post-Operative and 6 months after surgery

Study Arms (2)

Albumin-PRF group

EXPERIMENTAL

Immediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel

Procedure: Immediate Implant Placement and Alb-PRF

L-PRF group

EXPERIMENTAL

Immediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF ( L-PRF Block )

Procedure: Immediate Implant Placement and L-PRF

Interventions

Immediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel

Albumin-PRF group

Immediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF

L-PRF group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The presence of non-restorable mandibular molar.
  • Patient 18-45 years old
  • Intact buccal and lingual walls
  • Good oral hygiene.
  • Prescence of sufficient restorative space.
  • Jumping gap more than 2 mm.

You may not qualify if:

  • Proximity of anatomical structures
  • Acute localized infection (suppuration at the surgical field)
  • Patients on chemotherapy or radiotherapy.
  • Patients who have systemic disorders (diseases) {diabetes mellitus, autoimmune disease, …etc},
  • Pregnant patients.
  • Smoking and Alcohols.
  • Presence of periapical pathology affecting the neighboring teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University, Faculty of Dentistry

Kafr ash Shaykh, Kafrelsheikh, Egypt

RECRUITING

Central Study Contacts

Mostafa Mohamed Fayed, Demonstrator of Periodontology

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of Periodontology

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 7, 2025

Study Start

August 20, 2025

Primary Completion

February 10, 2026

Study Completion (Estimated)

February 10, 2027

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations