Tooth Loss and RehabillitationNCT07797452
Comparison Between Xenograft and Extended PRF as Jumping Gap Grafting Material Versus Natural Healing of the Socket Without Any Material.
A study testing Xenograft jumping gap filling material and e-PRF jumping gap filling material in people with Tooth Loss and Rehabillitation and Immediate Implant Placement in Mandibular Molar Extraction Sockets, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tooth Loss and Rehabillitation, Immediate Implant Placement in Mandibular Molar Extraction Sockets, Jumping Gap
- What is being tested?
- Xenograft jumping gap filling material and e-PRF jumping gap filling material
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2025to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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.
- Conditions
- Tooth Loss and Rehabillitation, Immediate Implant Placement in Mandibular Molar Extraction Sockets, Jumping Gap
- Being tested
- Xenograft jumping gap filling material, e-PRF jumping gap filling material
- Keywords
- Jumping Gap, Immediate Implant Placement, Molar Extraction Sockets, Xenograft, e-PRF
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenograft jumping gap filling materialProcedure or surgery
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 materialProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ten immediate mandibular molar implant placement with xenograft filling materialof the jumping gap. | Experimental | Not described Receives: Procedure: Xenograft jumping gap filling material |
| Ten immediate mandibular molar implant placement with e-PRF filling material of the jumping gap. | Experimental | Not described Receives: Procedure: e-PRF jumping gap filling material |
| Immediate mandibular molar implant placement without grafting material. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear and Volumetric Digital Evaluation of implant site
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.
Measured: preoperative, 1 month, 3 months and 6 months postoperative.
Radiographic Evaluation of Implant Site Volumetric Change
CBCT examinations obtained and three-dimensional superimposition of baseline and follow-up DICOM datasets used to evaluate hard-tissue dimensional changes.
Measured: preoperatively, immediately after implant placement, and at 6 months
Secondary outcomes (2)
Implant Stability
Implant stability assessment using resonance frequency analysis with the Osstell device to record implant stability quotient (ISQ) values.
Measured: at implant placement, 3 months and 6 months postoperative.
Modified Sulcus Bleeding Index
Evaluation of peri-implant soft-tissue health using the modified sulcus bleeding index (mSBI).
Measured: at 3 and 6 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start2 Feb 2025
- Primary completion25 Aug 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Loss and RehabillitationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mohamed Kamal Abdelwahab, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797452
- Sponsor's protocol ID
- A01012024OS
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Digital Evaluation of Different Jumping Gap Grafting Materials Versus No Grafting Material in Immediate Lower Molar Implant Placement
- ClinicalTrials.gov ID
- NCT07797452
- Acronym / sponsor ID
- A01012024OS
- Conditions
- Tooth Loss and Rehabillitation, Immediate Implant Placement in Mandibular Molar Extraction Sockets, Jumping Gap
- Keywords
- Jumping Gap, Immediate Implant Placement, Molar Extraction Sockets, Xenograft, e-PRF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ten immediate mandibular molar implant placement with xenograft filling materialof the jumping gap. | Experimental | Procedure: Xenograft jumping gap filling material |
| Ten immediate mandibular molar implant placement with e-PRF filling material of the jumping gap. | Experimental | Procedure: e-PRF jumping gap filling material |
| Immediate mandibular molar implant placement without grafting material. | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenograft jumping gap filling materialafter tooth extraction and implant placement, xenograft particulates were placed to fill the jumping gap before sealing the socket with a chairside socket sealing abutment. | Procedure or surgery | Ten immediate mandibular molar implant placement with xenograft filling materialof the jumping gap. |
| e-PRF jumping gap filling materialafter 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. | Procedure or surgery | Ten immediate mandibular molar implant placement with e-PRF filling material of the jumping gap. |
Primary outcome
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.
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.
2 secondary outcomes
Implant Stability
Time frame: at implant placement, 3 months and 6 months postoperative.
Modified Sulcus Bleeding Index
Time frame: at 3 and 6 months postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Tooth Loss and Rehabillitation
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xenograft jumping gap filling material and e-PRF jumping gap filling material in people with Tooth Loss and Rehabillitation and Immediate Implant Placement in Mandibular Molar Extraction Sockets, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear and Volumetric Digital Evaluation of implant site (time frame: preoperative, 1 month, 3 months and 6 months postoperative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.