Efficacy Of Eggshell-Derived Nanohydroxyapatite Based Mineralized Plasmatic Matrix Versus Xenogeneic Based Mineralized Plasmatic Matrix in Posterior Mandibular Socket Preservation: A Randomized Controlled Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Cairo University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in bone density
Study Overview
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.
Detailed Description
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). This resorption can compromise the structural foundation required for future dental restorations, such as implants, bridges, or dentures.
Maintaining the alveolar ridge's volume and contour is crucial for the successful placement of dental implants. Adequate bone volume ensures that implants can be securely anchored, providing the necessary stability and support for prosthetic teeth (Jung et al., 2013). Without sufficient bone, additional procedures such as bone grafting may be required, which can increase treatment time, cost, and patient discomfort. Bone loss can lead to changes in the facial structure, such as sunken cheeks and lips, which can affect a patient's appearance and self-esteem.
By preserving the socket, dental professionals can help maintain the natural contour of the jawline and facial aesthetics (Schropp et al., 2003).
Socket preservation can reduce the risk of complications associated with bone loss, such as the migration of adjacent teeth, changes in occlusion, and the development of periodontal pockets. These complications can lead to further dental issues and complicate future restorative procedures (Ten Heggeler et al., 2011).
The use of appropriate materials in socket preservation can promote bone regeneration and soft tissue healing, leading to better clinical outcomes and patient satisfaction (Vignoletti et al., 2012).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria:
- •Patient having at least one hopeless posterior mandibular tooth requires extracted
- •18 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
Exclusion Criteria
- •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
Arms & Interventions
eggshell-derived nanohydroxyapatite-based mineralized plasmatic matrix along with 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 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).
Intervention: Socket preservation using eggshell-derived nanohydroxyapatite-based mineralized plasmatic matrix along with platelet-rich fibrin (PRF). (Procedure)
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 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).
Intervention: Socket preservation using deproteinized bovine bone mineral (DBBM) xenograft along with platelet-rich fibrin (PRF). (Procedure)
Outcomes
Primary Outcomes
Change in bone density
Time Frame: after 4 months postoperatively.
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.
Secondary Outcomes
- 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)
Investigators
Mohammad Fardous Alfardous Alazm
Principal Investigator Mohammad Fardous
Cairo University