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

Overview

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

Interventions

• Procedure Immediate Implant Placement
  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)

Primary outcome measures

• Marginal (crestal) bone loss (MBL). [Time frame: after surgery and 6 months after surgery]

Secondary outcome measures (4)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of dentistry kafrelsheikh university — Kafrelsheikh

Identifiers

NCT: NCT06809829 · KFSIRB200-482

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗