Clinical trial NCT06809829: Evaluation of Doxycycline Nanoparticle With Gelatin Sponge on Immediate Implant in Esthetic Region
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immediate Implant Placement
Keywords: Immediate Implant Placement
Nanoparticles
Doxycycline
Gelatin Sponge
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Marginal (crestal) bone loss (MBL).
timeFrame: after surgery and 6 months after surgery
Secondary outcomes:
measure: Pink Esthetic Score
timeFrame: before the surgery, 3 months and 6 months after the surgery
measure: Peri-Implant Periodontal Probing depth (PPD):
timeFrame: 3 months and 6 months after the surgery
measure: Peri-implant vertical bone level.
timeFrame: after surgery and 6 months after surgery
measure: Implant stability
timeFrame: at the time of surgery, 3 months and 6 months post surgery
Other outcomes:
Locations:
city: Kafrelsheikh
country: Egypt
facility: Faculty of dentistry kafrelsheikh university
Study officials:
References: