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Clinical Trials in Egypt / NCT07404098
Active, not recruiting Not applicable

Efficacy Of Eggshell-Derived Nanohydroxyapatite Based Mineralized Plasmatic Matrix Versus Xenogeneic Based Mineralized Plasmatic Matrix in Posterior Mandibular Socket Preservation

NCT07404098 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2026-04-14

Condition(s) studied

Alveolar Bone ResorptionSocket PreservationWound HealingNano-hydroxyapatite

Investigational drug(s) / intervention(s)

Socket preservation using eggshell-derived nanohydroxyapatite-based mineralized plasmatic matrix along with platelet-rich fibrin (PRF).Socket preservation using deproteinized bovine bone mineral (DBBM) xenograft along with platelet-rich fibrin (PRF).

Socket preservation using eggshell-derived nanohydroxyapatite-based mineralized plasmatic matrix along with platelet-rich fibrin (PRF).: A whole venous blood (10 ml) is obtained from the patient to prepare the PRF. The 10 ml are divided into: 5 ml for mixing and 5 ml to be used as a covering membrane. Tooth extraction is done comprising minimal surgical trauma to the surrounding bone using periotomes and remaining root forceps. Then, debriding the socket using bone curette will be done. PRF will be prepared as instructed by (Choukroun et al., 2006) The Blood is obtained from the patient and centrifuged for 3000rpm for 10 min The first (5 ml) of PRF will be mixed with the eggshell nanohydroxyapatite- based matrix (EnHA) and it will be placed inside the socket. The second (5ml) of PRF will be used as a membrane. The suturable membrane formation is prepared from fibrin clot by pressing it in PRF Box. Primary closure is done by appropriate suturing technique (Criss Cross Suture/ Figure of 8.)by using resorbable suture material (Vicryl).

Socket preservation using deproteinized bovine bone mineral (DBBM) xenograft along with platelet-rich fibrin (PRF).: A whole venous blood (10 ml) is obtained from the patient to prepare the PRF. The 10 ml are divided into: 5 ml for mixing and 5 ml to be used as a covering membrane. Tooth extraction is done comprising minimal surgical trauma to the surrounding bone using periotomes and remaining root forceps. Then, debriding the socket using bone curette will be done. PRF will be prepared as instructed by (Choukroun et al., 2006) The Blood is obtained from the patient and centrifuged for 3000rpm for 10 min. The first (5 ml) of PRF will be mixed with Deproteinized Bovine Bone Mineral (DBBM) and it will be placed inside the socket. The second (5ml) of PRF will be used as a membrane. The suturable membrane formation is prepared from fibrin clot by pressing it in PRF Box. Primary closure is done by appropriate suturing technique (Criss Cross Suture/ Figure of 8.) by using resorbable suture material (Vicryl).

Study summary

After tooth extraction, the alveolar bone, which supports the teeth, undergoes a natural resorption process. This bone loss can be significant, especially in the first few months post-extraction, leading to a reduction in both bone height and width (Araújo et al ,. 2005) Generally, the goal of alveolar ridge preservation is to maximize bone formation while maintaining good soft tissue architecture, As socket preservation has proved high clinical efficacy in maintaining alveolar ridge high and width, there are many materials that have been proposed such as: autogenous bone grafts, allografts, xenografts, alloplasts, dentin graft and PRF. Unfortunately, the previously mentioned grafting material has several limitations have more such as high cost, biocompatibility, osteoinductive limitations and the need for a second surgical site. These limitations encouraged the researchers to test alternative materials and techniques to provide comparable or superior outcomes with fewer drawbacks.

One of the newly introduced materials is eggshell derived nanohydroxyapatite (EnHA). Eggshell-derived nanohydroxyapatite (EnHa) represents a novel and potentially superior alternative due to its biocompatible, osteoconductive, and osteoinductive bone substitute. Preliminary studies suggest that this material.

The synergistic effect of PRF when combined with various graft materials has also been extensively studied. when PR combined with bone grafting materials, it results in enhanced osteoconductive properties of graft materials and promotes efficient bone regeneration. (Yilmaz et al., 2017).

However, up till now, there are no sufficient studies on the clinical efficacy of EnHA as a cheaper and readily available alternative which has superior clinical properties especially when combined with PRF compared to standard xenografts.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
* Inclusion criteria: 1. Patient having at least one hopeless posterior mandibular tooth requires extracted 2. 18 years old or older. 3. Non- smoker 4. Motivated patients with good enough understanding of oral health measurements and importance 5. Medically fit patients. 6. No acute infections, pus formation, socket and bony discharges. 7. Compliant the patient to ensure the follow up * Exclusion criteria: 1. Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of \>6 mg/ml of nicotine). 2. Pregnant subjects. 3. Presence of active infection or severe inflammation in the intervention zone. 4. Relevant medical history contraindicates implant surgery. 5. Immunosuppression (e.g.: HIV, solid-organ transplants). 6. Head and neck-irradiated patients in the past 5 years. 7. Regular intake of bisphosphonates, anticoagulants as: aspirin, or anti-inflammatories. 8. Patients with anemia or Thrombocytopenia. 9. Chronic drug abuse or alcoholic habits. 10. Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score \>15%) and lack of motivation. 11. Uncontrolled diabetes (reported levels of glycated hemoglobin exceeding 7%). 12. Uncontrolled and /or untreated periodontal disease (Active Periodontitis). 13. Patients with significant comorbidity such as recent heart attack or coagulation disorder. 14. Patients with a history of allergies. 15. Mentally and physically handicapped patients

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cairo University Cairo Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07404098 on ClinicalTrials.gov ↗ ← All trials in Egypt