Tooth LossimplantNCT06945562
Influence of Collagen Cone on Jumping Gap Management Around Dental Implants
A study testing collagen cone (resorbable material used for socket sealing ) and Placement of Immediate Dental Implant Only in people with Tooth Loss, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The present study will be performed to assess the clinical and radiographic effect of collagen cone for bone growth in immediate implants. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Tooth Loss
- What is being tested?
- collagen cone (resorbable material used for socket sealing ) and Placement of Immediate Dental Implant Only
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Mar 2025
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 30-50 years.
- Good general health.
- Adequate bone volume at the implant site.
- Non-compromised periodontal status.
Who cannot join
- Presence of parafunctional habits (e.g., bruxism, clenching, excessive gum chewing, lip or fingernail biting).
- Smokers.
- Patients receiving chemotherapy or radiotherapy.
- Alcohol or drug abuse.
- Pregnancy and lactation.
- Use of drugs that may affect bone metabolism.
Trial locations and contacts
1 site in 1 country.
About this study
The present study will be performed to assess the clinical and radiographic effect of collagen cone for bone growth in immediate implants.
Read the detailed description
Improve width and length of buccal plate of alveolar bone, bone density around dental implamts in esthetics zone.
- Conditions
- Tooth Loss
- Being tested
- collagen cone (resorbable material used for socket sealing ), Placement of Immediate Dental Implant Only
- Keywords
- immediate implant, collagen cone, esthatic zone, jumping gap
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen cone (resorbable material used for socket sealing )Device
The test group include those sites enrolled for placement of immediate dental implant (N=8) with application of collagen cone
Placement of Immediate Dental Implant OnlyProcedure or surgery
Participants will receive placement of an immediate dental implant without any additional material (N=8).
| Study group | Role | What they receive |
|---|---|---|
| Immediate Dental Implant Placement only | Active comparator | The control group will be assigned for the sites that undergo placement of immediate dental implant (N=8) only. Receives: Procedure: Placement of Immediate Dental Implant Only |
| Immediate Dental Implant Placement with Collagen Cone | Active comparator | The test group include those sites enrolled for placement of immediate dental implant (N=8) with application of collagen cone Receives: Device: collagen cone (resorbable material used for socket sealing ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Bleeding Index
Assessment of peri-implant soft tissue bleeding using the modified bleeding index:
0 - No bleeding
- - Isolated bleeding spots
- - Confluent bleeding
- - Profuse bleeding unit of Measure: Score (0-3)
Measured: from 0 to 9 month
Vertical Bone Loss
Measurement of marginal vertical bone height loss around dental implants using CBCT imaging Unit of Measure: Millimeters (mm)
Measured: from 0 to 9 month
Buccal Plate Width
Measurement of buccal bone plate width at the implant site using CBCT. Unit of Measure: Millimeters (mm)
Measured: From 0 to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Apr 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hala Fathy Abd El Fattah, Faculty of Dental Medicine for Girls
- Investigators
- Abeer Gawish, professor, Study director, Al-Azhar Universitylobna Abd-El Aziz, Lecturer, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945562
- Sponsor's protocol ID
- OMPDR-103-2h
- Acronym
- implant
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Collagen Cone on Jumping Gap Management Around Dental Implants
- ClinicalTrials.gov ID
- NCT06945562
- Acronym / sponsor ID
- implant / OMPDR-103-2h
- Conditions
- Tooth Loss
- Keywords
- immediate implant, collagen cone, esthatic zone, jumping gap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 25 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.
The present study will be performed to assess the clinical and radiographic effect of collagen cone for bone growth in immediate implants.
Detailed description
Improve width and length of buccal plate of alveolar bone, bone density around dental implamts in esthetics zone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Dental Implant Placement only | Active comparator | Procedure: Placement of Immediate Dental Implant OnlyThe control group will be assigned for the sites that undergo placement of immediate dental implant (N=8) only. |
| Immediate Dental Implant Placement with Collagen Cone | Active comparator | Device: collagen cone (resorbable material used for socket sealing )The test group include those sites enrolled for placement of immediate dental implant (N=8) with application of collagen cone |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged between 30-50 years.
- Good general health.
- Adequate bone volume at the implant site.
- Non-compromised periodontal status.
Key exclusion criteria (6 listed)
- Presence of parafunctional habits (e.g., bruxism, clenching, excessive gum chewing, lip or fingernail biting).
- Smokers.
- Patients receiving chemotherapy or radiotherapy.
- Alcohol or drug abuse.
- Pregnancy and lactation.
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 |
|---|---|---|
| collagen cone (resorbable material used for socket sealing )The test group include those sites enrolled for placement of immediate dental implant (N=8) with application of collagen cone | Device | Immediate Dental Implant Placement with Collagen Cone |
| Placement of Immediate Dental Implant OnlyParticipants will receive placement of an immediate dental implant without any additional material (N=8). | Procedure or surgery | Immediate Dental Implant Placement only |
Primary outcome
Clinical Bleeding Index
Time frame: from 0 to 9 month
Assessment of peri-implant soft tissue bleeding using the modified bleeding index: 0 - No bleeding 1. - Isolated bleeding spots 2. - Confluent bleeding 3. - Profuse bleeding unit of Measure: Score (0-3)
Vertical Bone Loss
Time frame: from 0 to 9 month
Measurement of marginal vertical bone height loss around dental implants using CBCT imaging Unit of Measure: Millimeters (mm)
Buccal Plate Width
Time frame: From 0 to 9 months
Measurement of buccal bone plate width at the implant site using CBCT. Unit of Measure: Millimeters (mm)
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 25 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Tooth Loss
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Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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.
Abeer Gawish, professor study director
Al-Azhar University
lobna Abd-El Aziz, Lecturer study director
Al-Azhar 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 collagen cone (resorbable material used for socket sealing ) and Placement of Immediate Dental Implant Only in people with Tooth Loss, run by Faculty of Dental Medicine for Girls 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 6 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 25 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?
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?
Clinical Bleeding Index (time frame: from 0 to 9 month). The study lists 3 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 25 Apr 2025.