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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07797452
Enrollment
30
Registered
2026-09-01
Start date
2025-02-02
Completion date
2026-08-25
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Implant Placement in Mandibular Molar Extraction Sockets, Jumping Gap, Tooth Loss and Rehabillitation

Keywords

Jumping Gap, Immediate Implant Placement, Molar Extraction Sockets, Xenograft, e-PRF

Brief summary

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.

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.

Interventions

PROCEDUREXenograft 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.

PROCEDUREe-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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Linear and Volumetric Digital Evaluation of implant sitepreoperative, 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.
Radiographic Evaluation of Implant Site Volumetric Changepreoperatively, immediately after implant placement, and at 6 monthsCBCT examinations obtained and three-dimensional superimposition of baseline and follow-up DICOM datasets used to evaluate hard-tissue dimensional changes.

Secondary

MeasureTime frameDescription
Implant Stabilityat 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.
Modified Sulcus Bleeding Indexat 3 and 6 months postoperative.Evaluation of peri-implant soft-tissue health using the modified sulcus bleeding index (mSBI).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026