Immediate Implant PlacementNCT06809829
Evaluation of Doxycycline Nanoparticle With Gelatin Sponge on Immediate Implant in Esthetic Region
A study testing Immediate Implant Placement in people with Immediate Implant Placement, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to Evaluate the effect of Doxycycline nanoparticles along with gelatin sponge in immediate implant cases in esthetic zone. The main question it aims to answer is: Does the application of doxycycline nanoparticles with gelatin sponge improve the clinical and radiographic outcomes of… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Immediate Implant Placement
- What is being tested?
- Immediate Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2025to Feb 2027
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The presence of non-restorable single-rooted maxillary centrals, canines or premolars.
- Sufficient bone volume.
- Good oral hygiene.
- The remaining space between the socket and the fixture equals or more than 2mm at the coronal third of the socket.
- Sufficient bone width (≥ 1 mm) in the buccal plate of the remaining bone to place an implant confirmed by cone beam computer tomography (CBCT).
Who cannot join
- Insufficient bone volume.
- Active infection.
- Patients on chemotherapy or radiotherapy.
- Patients who have systemic disorders {uncontrolled diabetes mellitus, autoimmune disease, …etc},
- Pregnant patients,
- Patients with bone diseases
- Presence of periapical pathology affecting the neighbouring teeth.
- Smokers.
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, 1 recruiting
- Recruiting
Faculty of dentistry kafrelsheikh university
Kafrelsheikh, Kafrelsheikh, 12345
Enas Ahmed Elgendy, Professor, +201003508797, Dentist@den.kfs.edu.eg
About this study
Official title: Clinical and Radiographic Evaluation of Doxycycline and Doxycycline Loaded Nanoparticles With Gelatin Sponge on Immediate Implant Placement in Esthetic Zone: A Randomized Clinical Trial
The goal of this clinical trial is to Evaluate the effect of Doxycycline nanoparticles along with gelatin sponge in immediate implant cases in esthetic zone. The main question it aims to answer is:
Does the application of doxycycline nanoparticles with gelatin sponge improve the clinical and radiographic outcomes of immediate implant cases in esthetic zone?
Read more
Researchers will compare eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline loaded gelatin nanoparticles along with gelatin sponge (group A) with eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline along with gelatin sponge (group B). to see if the doxycycline loaded nanoparticles will improve the clinical and radiographic outcomes of the immediate implant .
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
- Conditions
- Immediate Implant Placement
- Being tested
- Immediate Implant Placement
- Keywords
- Immediate Implant Placement, Nanoparticles, Doxycycline, Gelatin Sponge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Implant PlacementProcedure or surgery
Eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline loaded gelatin nanoparticles along with gelatin sponge (group A) Eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline along with gelatin sponge (group B)
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement with doxycycline loaded gelatin nano particles and gelatin sponge | Experimental | Not described Receives: Procedure: Immediate Implant Placement |
| Immediate Implant Placement with Doxycyline and Gelatin Sponge | Active comparator | Not described Receives: Procedure: Immediate Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal (crestal) bone loss (MBL).
Radiographic examination of the patients will be done firstly pre-operative then just after the surgical procedures as a base point and at six months follow-up period post-operative by using CBCT (carestream 9600). On Demand3D program will be used for image reconstruction and analysis. For the calculation of marginal (crestal) bone loss (MBL), the implant will be used as a reference by adjusting the cross-sectional long axis in the center of the implant and bisecting it. A line will be drawn parallel to the implant, starting at the crest of the bony cortical plate of bone and ending at the apical level of the implant; height will be recorded in millimeters immediately and 6 months postoperative. The same process will be repeated from the palatal direction.
Measured: after surgery and 6 months after surgery
Secondary outcomes (4)
Pink Esthetic Score
The patients will be photographed to measure the pink esthetic sore before the surgery, 3 months, and 6 months after the surgery.
Measured: before the surgery, 3 months and 6 months after the surgery
Peri-Implant Periodontal Probing depth (PPD):
This index depends mainly on the usage of 0.5 mm Michigan O probe with graduations. Measurements will be evaluated at six sites per implant i.e., the disto-facial surface, mid facial surface, mesio-facial surface, mesio-lingual surface, mid lingual surface and disto-lingual surfaces of the implant. PPD will be measured by taking the reading from the free gingival margin to the base of the pocket. The mean score of the implant will be obtained by adding the six scores and dividing it by six. Measurements will be recorded to the nearest 0.5 mm six months after implant placement (prosthetic phase) and three months after the prosthesis placement.
Measured: 3 months and 6 months after the surgery
Peri-implant vertical bone level.
Measurement will be carried out on four aspects (mesial, distal, buccal and lingual) around all implants of the selected OPGs using CBCT (carestream 9600). On Demand3D program will be used for image reconstruction and analysis. The implant shoulder and the bone ridge will be used as reference points. The distance between the implant shoulder and the bone crest directly in contact with the implant will be measured with the ruler function. The presence of peri-implant bone defect will be determined by the percent of bone loss related to the length of the implant.
Measured: after surgery and 6 months after surgery
Implant stability
The transducer of the RFA device (Osstell®. Osstell, Baltimore) will be placed by hand tightening onto implant fixture. The implant stability quotient (ISQ) values will be measured both parallel and perpendicular to alveolar ridge of the jaw. The final ISQ value for each implant will be the mean of ISQ values. ISQ values will be measured again at re-entry after 3, 6 months for each implant.
Measured: at the time of surgery, 3 months and 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant PlacementStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Othman Fathy Othman El-Kersh, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809829
- Sponsor's protocol ID
- KFSIRB200-482
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Doxycycline and Doxycycline Loaded Nanoparticles With Gelatin Sponge on Immediate Implant Placement in Esthetic Zone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06809829
- Acronym / sponsor ID
- KFSIRB200-482
- Conditions
- Immediate Implant Placement
- Keywords
- Immediate Implant Placement, Nanoparticles, Doxycycline, Gelatin Sponge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Feb 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 goal of this clinical trial is to Evaluate the effect of Doxycycline nanoparticles along with gelatin sponge in immediate implant cases in esthetic zone. The main question it aims to answer is:
Does the application of doxycycline nanoparticles with gelatin sponge improve the clinical and radiographic outcomes of immediate implant cases in esthetic zone?
Researchers will compare eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline loaded gelatin nanoparticles along with gelatin sponge (group A) with eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline along with gelatin sponge (group B). to see if the doxycycline loaded nanoparticles will improve the clinical and radiographic outcomes of the immediate implant .
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement with doxycycline loaded gelatin nano particles and gelatin sponge | Experimental | Procedure: Immediate Implant Placement |
| Immediate Implant Placement with Doxycyline and Gelatin Sponge | Active comparator | Procedure: Immediate Implant Placement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The presence of non-restorable single-rooted maxillary centrals, canines or premolars.
- Sufficient bone volume.
- Good oral hygiene.
- The remaining space between the socket and the fixture equals or more than 2mm at the coronal third of the socket.
- Sufficient bone width (≥ 1 mm) in the buccal plate of the remaining bone to place an implant confirmed by cone beam computer tomography (CBCT).
Key exclusion criteria (8 listed)
- Insufficient bone volume.
- Active infection.
- Patients on chemotherapy or radiotherapy.
- Patients who have systemic disorders {uncontrolled diabetes mellitus, autoimmune disease, …etc},
- Pregnant 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 |
|---|---|---|
| Immediate Implant PlacementEight patients undergoing immediate implant placement with the buccal gap filled with doxycycline loaded gelatin nanoparticles along with gelatin sponge (group A) Eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline along with gelatin sponge (group B) | Procedure or surgery | Immediate Implant Placement with Doxycyline and Gelatin Sponge, immediate implant placement with doxycycline loaded gelatin nano particles and gelatin sponge |
Primary outcome
Marginal (crestal) bone loss (MBL).
Time frame: after surgery and 6 months after surgery
Radiographic examination of the patients will be done firstly pre-operative then just after the surgical procedures as a base point and at six months follow-up period post-operative by using CBCT (carestream 9600). On Demand3D program will be used for image reconstruction and analysis. For the calculation of marginal (crestal) bone loss (MBL), the implant will be used as a reference by adjusting the cross-sectional long axis in the center of the implant and bisecting it. A line will be drawn parallel to the implant, starting at the crest of the bony cortical plate of bone and ending at the apical level of the implant; height will be recorded in millimeters immediately and 6 months postoperative. The same process will be repeated from the palatal direction.
4 secondary outcomes
Pink Esthetic Score
Time frame: before the surgery, 3 months and 6 months after the surgery
Peri-Implant Periodontal Probing depth (PPD):
Time frame: 3 months and 6 months after the surgery
Peri-implant vertical bone level.
Time frame: after surgery and 6 months after surgery
Implant stability
Time frame: at the time of surgery, 3 months and 6 months post surgery
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 5 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Implant Placement in people with Immediate Implant Placement, run by Kafrelsheikh 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal (crestal) bone loss (MBL). (time frame: after surgery and 6 months after surgery). 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 5 Feb 2025.