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

NCT07404098 | Active Not Recruiting

• 1 other identifier: per3322026
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Resorption; Socket Preservation; Wound Healing; Nano-hydroxyapatite

Keywords

bone gain; xenograft; EnHa; socket preservation; prf

Outcome Measures

Primary Outcomes (1)

• Change in bone density

  CBCT scans will be performed at baseline and 4 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. Bone density measured using CBCT radiographs after 4 months later, and a 12\*12 mm² region of measurement used to assess the density in different points (Point A at the socket crest, Point B at the middle of the socket, Point C at the apex). The CBCT taken after 4 months will serve the purpose of superimposing the two scans and assessing the bone density changes after augmentation. These measurements will be denoted as HW-1, HW-3, and HW-5, respectively.

  after 4 months postoperatively.

Secondary Outcomes (3)

• Percentage of new vital bone formation

  After 4 months postoperatively

• Change in Percentage of residual bone graft

  after 4 months postoperatively

• Wound healing and pain

  10 days post operative and after 4 months postoperative

Study Arms (2)

eggshell-derived nanohydroxyapatite-based mineralized plasmatic matrix along with PRF

EXPERIMENTAL

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 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).

Procedure: Socket preservation using eggshell-derived nanohydroxyapatite-based mineralized plasmatic matrix along with platelet-rich fibrin (PRF).

deproteinized bovine bone mineral (DBBM) xenograft along with platelet-rich fibrin (PRF).

ACTIVE COMPARATOR

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 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).

Procedure: Socket preservation using deproteinized bovine bone mineral (DBBM) xenograft along with platelet-rich fibrin (PRF).

Interventions

Socket preservation using eggshell-derived nanohydroxyapatite-based mineralized plasmatic matrix along with platelet-rich fibrin (PRF). PROCEDURE

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).

eggshell-derived nanohydroxyapatite-based mineralized plasmatic matrix along with PRF

Socket preservation using deproteinized bovine bone mineral (DBBM) xenograft along with platelet-rich fibrin (PRF). PROCEDURE

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).

deproteinized bovine bone mineral (DBBM) xenograft along with platelet-rich fibrin (PRF).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having at least one hopeless posterior mandibular tooth requires extracted
• years old or older.
• Non- smoker
• Motivated patients with good enough understanding of oral health measurements and importance
• Medically fit patients.
• No acute infections, pus formation, socket and bony discharges.
• Compliant the patient to ensure the follow up

You may not qualify if:

• Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of \>6 mg/ml of nicotine).
• Pregnant subjects.
• Presence of active infection or severe inflammation in the intervention zone.
• Relevant medical history contraindicates implant surgery.
• Immunosuppression (e.g.: HIV, solid-organ transplants).
• Head and neck-irradiated patients in the past 5 years.
• Regular intake of bisphosphonates, anticoagulants as: aspirin, or anti-inflammatories.
• Patients with anemia or Thrombocytopenia.
• Chronic drug abuse or alcoholic habits.
• Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score \>15%) and lack of motivation.
• Uncontrolled diabetes (reported levels of glycated hemoglobin exceeding 7%).
• Uncontrolled and /or untreated periodontal disease (Active Periodontitis).
• Patients with significant comorbidity such as recent heart attack or coagulation disorder.
• Patients with a history of allergies.
• Mentally and physically handicapped patients

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Mona Darhous, Professor

  Cairo University

  STUDY DIRECTOR

• Mohammed Fardous Alfardous AlAzm, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Maie Esmaiel, Lecturer

  Cairo University

  STUDY CHAIR

• Mohamed Omara, Associate Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Mohammad Fardous

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: January 1, 2025
• Primary Completion: January 1, 2025
• Study Completion: May 2, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-04

Locations

EG (1)