Comparison Between Xenograft and Extended PRF as Jumping Gap Grafting Material Versus Natural Healing of the Socket Without Any Material.

September 3, 2026 updated by: Hossam Mohamed Kamal Abdelwahab, Mansoura University

Clinical and Digital Evaluation of Different Jumping Gap Grafting Materials Versus No Grafting Material in Immediate Lower Molar Implant Placement

This study aims to clinically and digitally evaluate immediate implants placed in mandibular molar extraction sockets and compare the outcomes of xenograft, e-PRF, and no grafting material within the jumping gap.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following atraumatic extraction and implant site preparation within the interradicular bone, the implant will be immediately inserted. A chairside customized healing abutment will then be fabricated to seal the extraction socket. According to group allocation, the jumping gap will be filled with xenograft, e-PRF, or left unfilled before placement of the customized healing abutment. Definitive prosthetic restoration will be delivered after three months of implant insertion.

  1. Clinical Evaluation:

    Implant stability will be assessed at implant placement and at 3 and 6 months using resonance frequency analysis with the Osstell device, with implant stability quotient (ISQ) values recorded.

    Peri-implant soft-tissue health will be assessed using the modified sulcus bleeding index (mSBI) at 3 and 6 months intervals.

  2. Digital Evaluation:

    Peri-implant soft-tissue dimensional changes will be assessed using intraoral optical scans obtained preoperatively and at 1, 3, and 6 months. The resulting STL files will be superimposed using a best-fit alignment algorithm to evaluate dimensional changes in the peri-implant soft tissues.

  3. Radiographic Evaluation:

CBCT examinations will be obtained preoperatively, immediately after implant placement, and at 6 months. Three-dimensional superimposition of baseline and follow-up DICOM datasets will be used to evaluate hard-tissue dimensional changes.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Faculty of Dentistry, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any partially dentate patients with non-restorable mandibular molar requiring dental extraction.
  • Extraction sockets with intact bony walls and interradicular bone.
  • Jumping gap more than 2mm.

Exclusion Criteria:

  • Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
  • Heavy smokers (≥ pack per day)
  • Pregnancy.
  • Patients with systemic diseases that absolutely contraindicate implant placement or para-functional habits (bruxism or clenching).
  • Patients with poor oral hygiene or aggressive periodontal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ten immediate mandibular molar implant placement with xenograft filling materialof the jumping gap.
Procedure: Xenograft jumping gap filling material
after tooth extraction and implant placement, xenograft particulates were placed to fill the jumping gap before sealing the socket with a chairside socket sealing abutment.
Experimental: Ten immediate mandibular molar implant placement with e-PRF filling material of the jumping gap.
Procedure: e-PRF jumping gap filling material
after tooth extraction and implant placement, e-PRF was prepared from the patient's collected blood and placed to fill the jumping gap before sealing the socket with a chairside socket sealing abutment.
No Intervention: Immediate mandibular molar implant placement without grafting material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear and Volumetric Digital Evaluation of implant site
Time Frame: preoperative, 1 month, 3 months and 6 months postoperative.
Peri-implant soft-tissue dimensional changes assessment using intraoral optical scans and resulting STL files superimposition using a best-fit alignment algorithm to evaluate dimensional changes in the peri-implant soft tissues.
preoperative, 1 month, 3 months and 6 months postoperative.
Radiographic Evaluation of Implant Site Volumetric Change
Time Frame: preoperatively, immediately after implant placement, and at 6 months
CBCT examinations obtained and three-dimensional superimposition of baseline and follow-up DICOM datasets used to evaluate hard-tissue dimensional changes.
preoperatively, immediately after implant placement, and at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability
Time Frame: at implant placement, 3 months and 6 months postoperative.
Implant stability assessment using resonance frequency analysis with the Osstell device to record implant stability quotient (ISQ) values.
at implant placement, 3 months and 6 months postoperative.
Modified Sulcus Bleeding Index
Time Frame: at 3 and 6 months postoperative.
Evaluation of peri-implant soft-tissue health using the modified sulcus bleeding index (mSBI).
at 3 and 6 months postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2025

Primary Completion (Actual)

August 25, 2026

Study Completion (Actual)

August 25, 2026

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A01012024OS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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