Evaluation of Doxycycline Nanoparticle With Gelatin Sponge on Immediate Implant in Esthetic Region

NCT06809829 | Recruiting

• 1 other identifier: KFSIRB200-482
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Immediate Implant Placement

Keywords

Immediate Implant Placement; Nanoparticles; Doxycycline; Gelatin Sponge

Outcome Measures

Primary Outcomes (1)

• 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.

  after surgery and 6 months after surgery

Secondary Outcomes (4)

• Pink Esthetic Score

  before the surgery, 3 months and 6 months after the surgery

• Peri-Implant Periodontal Probing depth (PPD):

  3 months and 6 months after the surgery

• Peri-implant vertical bone level.

  after surgery and 6 months after surgery

• Implant stability

  at the time of surgery, 3 months and 6 months post surgery

Study Arms (2)

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

Interventions

Immediate Implant Placement PROCEDURE

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)

Immediate Implant Placement with Doxycyline and Gelatin Sponge; immediate implant placement with doxycycline loaded gelatin nano particles and gelatin sponge

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of dentistry kafrelsheikh university

Kafrelsheikh, Kafrelsheikh, 12345, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator of Department of Periodontology, Oral Diagnosis and Oral Radiology at Faculty of Dentistry, Kafrelsheikh university

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

EG (1)