Bone VolumeNCT06962878
Assessment of Bone Volume Changes in Immediate Implant Placement Using Allograft Versus Xenograft in Mandibular Molars
A study testing Xenograft and Allograft in people with Bone Volume and Immediate Implant With Bone Graft, run by Cairo University at 1 site in Egypt.
Trial summary
Twenty recruited patients indicated for immediate implant placement in mandibular molar sites are divided into two groups, with each group containing ten patients. One group assigned for placement of xenograft after molar extraction and immediate implant placement, while the other group received allograft as… Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Bone Volume, Immediate Implant With Bone Graft
- What is being tested?
- Xenograft and Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2025to 5 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with non-restorable mandibular molars
- Both sexes with age range from 25 years to 40 years
- Good oral hygiene
- Adequate alveolar bone dimensions for implant replacement
- Adequate bone volume after extraction to achieve primary stability of the immediate implant
- Co-operative patient
Who cannot join
- Patients with any systemic disease as uncontrolled diabetes or osteoporosis
- Heavy smokers with smokers more than 10 cigarettes per day
- Pregnancy
- Patients with any signs of active infection or pus formation
- Patients undergoing chemotherapy or radiotherapy, immunocompromised patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo
Ahmed Mohamed Tawfik, BSc, +201095544285, ahmed-tawfik@dentistry.cu.edu.eg
About this study
Official title: Assessment of Bone Volume Changes in Immediate Implant Placement Using Allograft Versus Xenograft in Mandibular Molars: Randomized Clinical Trial
Twenty recruited patients indicated for immediate implant placement in mandibular molar sites are divided into two groups, with each group containing ten patients. One group assigned for placement of xenograft after molar extraction and immediate implant placement, while the other group received allograft as space-filling material.
- Conditions
- Bone Volume, Immediate Implant With Bone Graft
- Being tested
- Xenograft, Allograft
- Keywords
- Bone graft, Jumping gap, Xenograft, Allograft, Immediate implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenograftProcedure or surgery
The jumping gap and surrounding space will be augmented and packed with Xenograft
AllograftProcedure or surgery
The jumping gap and surrounding space will be augmented and packed with Allograft
| Study group | Role | What they receive |
|---|---|---|
| Xenograft | Active comparator | Not described Receives: Procedure: Xenograft |
| Allograft | Experimental | Not described Receives: Procedure: Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone thickness in millimeters
Two CBCT images will be taken, one immediately after surgery (baseline) and the other at 6 months post-surgically
Measured: 6 months postoperative
Secondary outcomes (2)
Vertical bone height in millimeters
Two CBCT images will be taken, one 2 days after surgery (baseline) and the other at 6 months post-surgically
Measured: 6 months postoperative
Pain intensity
The pain will be recorded by participants at 1, 3, and 7 days after surgery using the Visual Analogue Scale (VAS), which ranges from 0 to 10. The minimum score is 0, indicating no pain, and the maximum score is 10, representing the worst possible pain. Higher scores on the VAS indicate worse outcomes in terms of pain experienced.
Measured: One week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start5 Aug 2025 (estimated)
- Primary completion5 Feb 2026 (estimated)
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Bone VolumeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Tawfik, Cairo University
- Investigators
- Mohamed Atef, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962878
- Sponsor's protocol ID
- Grafting in immediate implants
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Botticelli D, Berglundh T, Buser D, Lindhe J. The jumping distance revisited: An experimental study in the dog. Clin Oral Implants Res. 2003 Feb;14(1):35-42. doi: 10.1034/j.1600-0501.2003.140105.x.
PubMed 12562363Bhola M, Neely AL, Kolhatkar S. Immediate implant placement: clinical decisions, advantages, and disadvantages. J Prosthodont. 2008 Oct;17(7):576-81. doi: 10.1111/j.1532-849X.2008.00359.x. Epub 2008 Aug 26.
PubMed 18761580Lang NP, Pun L, Lau KY, Li KY, Wong MC. A systematic review on survival and success rates of implants placed immediately into fresh extraction sockets after at least 1 year. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:39-66. doi: 10.1111/j.1600-0501.2011.02372.x.
PubMed 22211305Dimitriou R, Mataliotakis GI, Angoules AG, Kanakaris NK, Giannoudis PV. Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury. 2011 Sep;42 Suppl 2:S3-15. doi: 10.1016/j.injury.2011.06.015. Epub 2011 Jun 25.
PubMed 21704997Khoury F, Hanser T. Mandibular bone block harvesting from the retromolar region: a 10-year prospective clinical study. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):688-97. doi: 10.11607/jomi.4117.
PubMed 26009921Schropp L, Isidor F. Timing of implant placement relative to tooth extraction. J Oral Rehabil. 2008 Jan;35 Suppl 1:33-43. doi: 10.1111/j.1365-2842.2007.01827.x.
PubMed 18181932Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13.
PubMed 33438320Howe MS, Keys W, Richards D. Long-term (10-year) dental implant survival: A systematic review and sensitivity meta-analysis. J Dent. 2019 May;84:9-21. doi: 10.1016/j.jdent.2019.03.008. Epub 2019 Mar 20.
PubMed 30904559Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.
PubMed 6809663Kononen E, Gursoy M, Gursoy UK. Periodontitis: A Multifaceted Disease of Tooth-Supporting Tissues. J Clin Med. 2019 Jul 31;8(8):1135. doi: 10.3390/jcm8081135.
PubMed 31370168
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Volume Changes in Immediate Implant Placement Using Allograft Versus Xenograft in Mandibular Molars: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06962878
- Acronym / sponsor ID
- Grafting in immediate implants
- Conditions
- Bone Volume, Immediate Implant With Bone Graft
- Keywords
- Bone graft, Jumping gap, Xenograft, Allograft, Immediate implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (estimated)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 5 Mar 2026 (estimated)
- First posted
- 8 May 2025 (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.
Twenty recruited patients indicated for immediate implant placement in mandibular molar sites are divided into two groups, with each group containing ten patients. One group assigned for placement of xenograft after molar extraction and immediate implant placement, while the other group received allograft as space-filling material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenograft | Active comparator | Procedure: Xenograft |
| Allograft | Experimental | Procedure: Allograft |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with non-restorable mandibular molars
- Both sexes with age range from 25 years to 40 years
- Good oral hygiene
- Adequate alveolar bone dimensions for implant replacement
- Adequate bone volume after extraction to achieve primary stability of the immediate implant
Key exclusion criteria (5 listed)
- Patients with any systemic disease as uncontrolled diabetes or osteoporosis
- Heavy smokers with smokers more than 10 cigarettes per day
- Pregnancy
- Patients with any signs of active infection or pus formation
- Patients undergoing chemotherapy or radiotherapy, immunocompromised patients
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 |
|---|---|---|
| XenograftThe jumping gap and surrounding space will be augmented and packed with Xenograft | Procedure or surgery | Xenograft |
| AllograftThe jumping gap and surrounding space will be augmented and packed with Allograft | Procedure or surgery | Allograft |
Primary outcome
Horizontal bone thickness in millimeters
Time frame: 6 months postoperative
Two CBCT images will be taken, one immediately after surgery (baseline) and the other at 6 months post-surgically
2 secondary outcomes
Vertical bone height in millimeters
Time frame: 6 months postoperative
Pain intensity
Time frame: One week postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 12562363Botticelli D, Berglundh T, Buser D, Lindhe J. The jumping distance revisited: An experimental study in the dog. Clin Oral Implants Res. 2003 Feb;14(1):35-42. doi: 10.1034/j.1600-0501.2003.140105.x.
- Background: PubMed 18761580Bhola M, Neely AL, Kolhatkar S. Immediate implant placement: clinical decisions, advantages, and disadvantages. J Prosthodont. 2008 Oct;17(7):576-81. doi: 10.1111/j.1532-849X.2008.00359.x. Epub 2008 Aug 26.
- Background: PubMed 22211305Lang NP, Pun L, Lau KY, Li KY, Wong MC. A systematic review on survival and success rates of implants placed immediately into fresh extraction sockets after at least 1 year. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:39-66. doi: 10.1111/j.1600-0501.2011.02372.x.
- Background: PubMed 21704997Dimitriou R, Mataliotakis GI, Angoules AG, Kanakaris NK, Giannoudis PV. Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury. 2011 Sep;42 Suppl 2:S3-15. doi: 10.1016/j.injury.2011.06.015. Epub 2011 Jun 25.
- Background: PubMed 26009921Khoury F, Hanser T. Mandibular bone block harvesting from the retromolar region: a 10-year prospective clinical study. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):688-97. doi: 10.11607/jomi.4117.
- Background: PubMed 18181932Schropp L, Isidor F. Timing of implant placement relative to tooth extraction. J Oral Rehabil. 2008 Jan;35 Suppl 1:33-43. doi: 10.1111/j.1365-2842.2007.01827.x.
- Background: PubMed 33438320Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13.
- Background: PubMed 30904559Howe MS, Keys W, Richards D. Long-term (10-year) dental implant survival: A systematic review and sensitivity meta-analysis. J Dent. 2019 May;84:9-21. doi: 10.1016/j.jdent.2019.03.008. Epub 2019 Mar 20.
- Background: PubMed 6809663Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.
- Background: PubMed 31370168Kononen E, Gursoy M, Gursoy UK. Periodontitis: A Multifaceted Disease of Tooth-Supporting Tissues. J Clin Med. 2019 Jul 31;8(8):1135. doi: 10.3390/jcm8081135.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Bone Volume
RecruitingPhase 1
Therapeutic RSK1 Targeting in Myeloid Malignancies
Myeloid Malignancy
Not yet recruitingPhase 4
Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain
Lumbar Disc Herniation, Lumbosacral Radiculopathy
Not yet recruiting
The Tooth Collar Technique
Insufficient Bone Volume Prior to Implant Surgery
Active, not recruitingPhase 2
A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis
Myelofibrosis
Active, not recruitingObservational study
Predicting Allograft Volume in Orthopedic Oncology: Hemielipsoid Formula vs Intraoperative Fluid-Fill Measurement
Bone Neoplasms, Musculoskeletal Neoplasms
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.
Mohamed Atef, PhD study director
Cairo University
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 and Allograft in people with Bone Volume and Immediate Implant With Bone Graft, run by Cairo 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 6 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: opening soon, as of the sponsor's last update on 6 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed Tawfik, BSc (+201095544285, ahmed-tawfik@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone thickness in millimeters (time frame: 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06962878, which also lists 10 linked publications.
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 6 Aug 2025.