Badly Broken Down Vital TeethNCT06916026
Immediate Implant Placement With Deproteinized Bovine Bone vs Deproteinized Bovine Bone With HAM Gel
A study testing Xenograft and Xenograft mixed with HAM gel. in people with Badly Broken Down Vital Teeth, run by Ain Shams University at 1 site in Egypt.
Trial summary
Statement of the problem: Immediate implant placement is faced with several problems. One of the most important is the jumping gap present after implant placement and whether it needs to be augmented or not. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Badly Broken Down Vital Teeth
- What is being tested?
- Xenograft and Xenograft mixed with HAM gel.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2025to 1 Aug 2025
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients at least 18 years old, with non-restorable first and second molars indicated for immediate implant placement in both arches.
- Patient who are medically free patients (American Society of Anesthesiologists I; ASA I)
- Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth.
- Minimum alveolar Bucco-palatal dimension of 7 mm.
Who cannot join
- Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
- Patients who are smokers.
- Presence of signs of active infection or pus formation.
- Absence or loss of buccal wall prior to implant placement.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of oral and dental medicine , Suez university
Suez, Suez Governorate, 12345
About this study
Official title: A Comparison of Immediate Implant Placement With Deproteinized Bovine Bone vs Deproteinized Bovine Bone With HAM Gel as Space Filling Material: A Randomized Controlled Trial.
Statement of the problem: Immediate implant placement is faced with several problems. One of the most important is the jumping gap present after implant placement and whether it needs to be augmented or not.
Aim: The aim of this study is to compare the effect of xenograft to xenograft mixed with HAM gel for grafting of the jumping gap in immediate implant placement in the molar region.
Read the detailed description
Aim: The aim of this study is to compare the effect of xenograft to xenograft mixed with HAM gel for grafting of the jumping gap in immediate implant placement in the molar region.
Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region requiring implant placement. They will be randomly allocated to two equal groups. Group A (control group, n=12) will receive immediate implants (grafting with xenograft), and group B (test group, n=12) will receive immediate implants (grafting with xenograft\& HAM). After implant placement, buccal bone thickness (1ry outcome), bone density (2nd outcome) and implant stability will be assessed (2nd outcome). The parameters will be assessed at baseline, 6 and 12 months. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
- Conditions
- Badly Broken Down Vital Teeth
- Being tested
- Xenograft, Xenograft mixed with HAM gel.
- Keywords
- Immediate implant placement, jumping gap, xenograft, Bone healing, Human amniotic membrane, bovine bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenograftProcedure or surgery
Gap distance grafting using xenograft
Xenograft mixed with HAM gel.Procedure or surgery
Gap distance grafting using xenograft mixed with HAM gel.
| Study group | Role | What they receive |
|---|---|---|
| Xenograft | Active comparator | Gap distance grafting using xenograft. Receives: Procedure: Xenograft |
| Xenograft mixed with HAM gel. | Active comparator | Gap distance grafting using xenograft mixed with HAM gel. Receives: Procedure: Xenograft mixed with HAM gel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal bone thickness
assessment of the buccal bone thickness using cone beam computed tomography (CBCT) in mm
Measured: At Baseline , Six months & 12 months
Secondary outcomes (1)
Implant stability
using Ostell
Measured: at baseline,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start7 Jan 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Badly Broken Down Vital TeethStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916026
- Sponsor's protocol ID
- immediate implant placement
- Status last verified
- Jan 2025
- First submitted
- 14 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Immediate Implant Placement With Deproteinized Bovine Bone vs Deproteinized Bovine Bone With HAM Gel as Space Filling Material: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06916026
- Acronym / sponsor ID
- immediate implant placement
- Conditions
- Badly Broken Down Vital Teeth
- Keywords
- Immediate implant placement, jumping gap, xenograft, Bone healing, Human amniotic membrane, bovine bone graft
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 8 Apr 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.
Statement of the problem: Immediate implant placement is faced with several problems. One of the most important is the jumping gap present after implant placement and whether it needs to be augmented or not.
Aim: The aim of this study is to compare the effect of xenograft to xenograft mixed with HAM gel for grafting of the jumping gap in immediate implant placement in the molar region.
Detailed description
Aim: The aim of this study is to compare the effect of xenograft to xenograft mixed with HAM gel for grafting of the jumping gap in immediate implant placement in the molar region.
Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region requiring implant placement. They will be randomly allocated to two equal groups. Group A (control group, n=12) will receive immediate implants (grafting with xenograft), and group B (test group, n=12) will receive immediate implants (grafting with xenograft\& HAM). After implant placement, buccal bone thickness (1ry outcome), bone density (2nd outcome) and implant stability will be assessed (2nd outcome). The parameters will be assessed at baseline, 6 and 12 months. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenograft | Active comparator | Procedure: XenograftGap distance grafting using xenograft. |
| Xenograft mixed with HAM gel. | Active comparator | Procedure: Xenograft mixed with HAM gel.Gap distance grafting using xenograft mixed with HAM gel. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients at least 18 years old, with non-restorable first and second molars indicated for immediate implant placement in both arches.
- Patient who are medically free patients (American Society of Anesthesiologists I; ASA I)
- Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth.
- Minimum alveolar Bucco-palatal dimension of 7 mm.
Key exclusion criteria (4 listed)
- Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
- Patients who are smokers.
- Presence of signs of active infection or pus formation.
- Absence or loss of buccal wall prior to implant placement.
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 |
|---|---|---|
| XenograftGap distance grafting using xenograft | Procedure or surgery | Xenograft |
| Xenograft mixed with HAM gel.Gap distance grafting using xenograft mixed with HAM gel. | Procedure or surgery | Xenograft mixed with HAM gel. |
Primary outcome
Buccal bone thickness
Time frame: At Baseline , Six months & 12 months
assessment of the buccal bone thickness using cone beam computed tomography (CBCT) in mm
1 secondary outcome
Implant stability
Time frame: at baseline,6 and 12 months
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 8 Apr 2025.
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3D Analysis of Soft Tissue Healing After Immediate Implant Placement Using PRF Vs HAM
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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 and Xenograft mixed with HAM gel. in people with Badly Broken Down Vital Teeth, run by Ain Shams 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 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?
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?
Buccal bone thickness (time frame: At Baseline , Six months & 12 months). 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 Apr 2025.