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OpenTrials
Completed

NCT Number: NCT07797452

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Egypt

About this study

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.

  • 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.

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xenograft jumping gap filling material

Procedure

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.

e-PRF jumping gap filling material

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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