CTRI/2023/07/055690
Not yet recruiting
Phase 3
Effect of lyophilized platelet-rich fibrin matrix (PRFM) in tooth extraction socket to foster alveolar ridge preservation for dental prosthetic rehabilitation - NI
Dr Anil Mathew0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr Anil Mathew
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Individuals within an age limit of 18 â?? 65 years for implant treatment
- •2\. Patients committed to the study and willing to sign the informed consent
- •3\. Healthy patients with an indication for dental extraction without other restorative treatment possibilities provided that the socket walls are intact.
- •4\. Patients who require prosthetic rehabilitation necessarily with an implant\-supported prosthesis after extraction.
- •5\. Patients indicated for implant treatment should be functionally dentulous with minimum of 20 teeth with 9to 10 pairs of contacting teeth and the proposed extraction site should be tooth bound and with opposing natural teeth or fixed restoration Tooth numbers below a minimum of 20
- •teeth, with nine to 10 pairs of contacting units, are associated with impaired masticatory efficiency, performance, and masticatory ability
- •6\. Patients who are willing for withdrawal of blood and socket reconstruction.
- •7\. Individuals who are willing to report at the required intervals for evaluation.
Exclusion Criteria
- •The participant may not enter the trial if ANY of the following apply:
- •1\.History of infectious diseases, bleeding disorder, or on medications that impair platelet function such as anticoagulant therapy.
- •2\.Patients on aspirin, history of cardiac problems (congenital/acquired heart disease, cerebrovascular accidents, or valvular disease) or undergone cardiac surgeries (coronary bypass surgery, valvular prosthesis surgeries).
- •3\. Individuals with known systemic risk factors for impaired wound healing, such as uncontrolled hypertension, uncontrolled diabetes, and bone metabolic diseases. (BP \>180/110 mm HG will be considered uncontrolled hypertension as it is contraindicated for implant causing impaired blood supply and the consequent hypoxia may negatively affect the healing process of bone around implants. HbA1C \> 8\.1% will be considered uncontrolled diabetes as it cause a delay in integration and implant stability).
- •4\.Severe periodontal disease, as patients with poor bone quality, severe alveolar bone resorption, and alveolar bone defects in tooth extraction sites or with acute periapical pathology
- •5\.Patients with removable prosthesis occluding or opposite to proposed extraction site planned for implant placement and who are functionally edentulous.
- •6\.Severely damaged extraction socket with more than 2 bone wall defect and hard tissue loss of more than 5mm (based on Extraction Defect Sounding Classification(EDS) evaluated by the tip of periodontal probe)
- •7\.Pregnant patients/breastfeeding mothers ( Radiation dose of CBCT pose risk to the fetus and high anxiety levels in an expectant mother during elective surgery can affect the development of a baby. Antibiotic therapy and NSAIDs after surgery might not be safe for breast milk and newborns.).
- •8\.Patients undergoing bisphosphonates therapy, exposure to head and neck radiation/ chemotherapy, or who are immune\-compromised.
- •9\. A habit of smoking \> 10 cigarettes/day or use of tobacco (More than 10 cigarettes has a significant correlation to implant failure. Cytotoxicity of nicotine to the cells involved in wound healing, vasoconstriction, and increased platelet adhesiveness and blood viscosity leading to the risk of microvascular occlusion, increases marginal bone loss).
Outcomes
Primary Outcomes
Not specified
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