An interventional study of Immediate Implant Placement in Immediate Implant Placement, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
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].
Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Procedure: Immediate Implant Placement
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)
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.
Time frame: after surgery and 6 months after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at the time of surgery, 3 months and 6 months post surgery
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Kafrelsheikh University