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

Not Applicable

Recruiting

• Conditions: Immediate Implant Placement

• Registration Number: NCT06809829
• Lead Sponsor: Kafrelsheikh University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-30
• Study Start: 2025-02
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-07
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Marginal (crestal) bone loss (MBL).	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.

Secondary Outcome Measures

Name	Time	Method
Pink Esthetic Score	before the surgery, 3 months and 6 months after the surgery	The patients will be photographed to measure the pink esthetic sore 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	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.
Peri-implant vertical bone level.	after surgery and 6 months after surgery	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.
Implant stability	at the time of surgery, 3 months and 6 months post surgery	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.

Trial Locations

Locations (1)

Faculty of dentistry kafrelsheikh university; 🇪🇬 Kafrelsheikh, Egypt