Effect of Bone Graft Material ON Peri-Implant Phenotype .

Overview

This prospective three-arm controlled interventional clinical study evaluates the effects of NanoBone alone and NanoBone combined with platelet-rich fibrin (PRF) on peri-implant hard and soft tissue phenotype after dental implant placement. Thirty-nine adult participants requiring dental implant therapy will be assigned to three groups of 13 using a repeating sequential 1-2-3 allocation sequence: implant placement alone (control), implant placement with NanoBone, or implant placement with NanoBone and PRF/CGF membrane. Clinical and radiographic outcomes will be assessed at baseline, immediately after surgery, 8 weeks after surgery, and 4 months after surgery, with an early postoperative assessment of pain, swelling, medication use, and wound healing.

This is a prospective, three-arm, controlled interventional clinical study conducted at the Department of Periodontics, College of Dentistry, Mustansiriyah University, Baghdad, Iraq. The study evaluates the effects of NanoBone alone and NanoBone combined with platelet-rich fibrin (PRF) or a CGF/PRF membrane on peri-implant hard and soft tissue phenotype after dental implant placement. The study includes 39 adults aged 18 to 70 years of either sex, with 13 participants assigned to each of three groups. Participants are recruited consecutively from patients seeking implant treatment at the postgraduate clinics of the Department of Periodontics. Allocation is performed using a pre-established repeating sequential 1-2-3 sequence. Because this sequence is predictable and is not true randomization, the study uses non-randomized sequential cyclic allocation. Group 1 is the control group and receives dental implant placement without an adjunctive graft or platelet concentrate. Group 2 receives dental implant placement with 200 mg of NMImETIC Swelling NanoBone (Tavakol BioMimetic Technologies Co., Iran; granule size 500-1000 micrometers), moistened with sterile 0.9% sodium chloride and distributed around the implant site. Group 3 receives dental implant placement with NanoBone sticky bone and a CGF/PRF membrane. For this group, venous blood is collected immediately before surgery in tubes without anticoagulant. Autologous fibrin glue is mixed with 200 mg of NanoBone to form a cohesive sticky-bone material, and the remaining blood components are processed to produce a concentrated growth factor/platelet-rich fibrin membrane that covers the graft before wound closure. All groups receive the same preoperative preparation, implant-placement protocol, postoperative care, and follow-up routine except for the assigned adjunctive treatment. Eligibility criteria include adults aged 18 to 70 years, ability to maintain oral hygiene and attend follow-up, healed edentulous ridges scheduled for delayed implant placement, adequate bone height and width for conventional implant placement, systemic health compatible with surgery and healing, and absence of infection or previous augmentation at the implant site. Exclusion criteria include uncontrolled systemic disease, pregnancy, active periodontal or periapical infection, severe ridge deficiency requiring complex reconstruction, metabolic bone disorders, bruxism or clenching, limited mouth opening, anatomical limitations preventing safe implant placement, inability or unwillingness to attend follow-up, and smoking, tobacco chewing, or alcohol consumption according to the study criteria. Clinical and radiographic assessments are performed at baseline, immediately after surgery, 7 days after surgery, 8 weeks after surgery, and 4 months after surgery. Baseline assessments include plaque index, bleeding on probing, keratinized tissue width, soft tissue thickness at crestal/occlusal, buccal, and lingual or palatal sites, ridge width, and calculated bone width. Immediate postoperative assessments include ridge width and radiographic mesial bone height. The 7-day visit includes patient-reported pain, swelling, medication use, wound healing, adverse events, and suture removal when appropriate. The 8-week assessment includes plaque index, bleeding on probing, keratinized tissue width, and ridge width. The 4-month assessment includes plaque index, bleeding on probing, keratinized tissue width, soft tissue thickness, ridge width, calculated bone width, and radiographic mesial peri-implant bone height. Measurements are obtained by a trained examiner using standardized reference points and a measurement stent. Cone-beam computed tomography is used for preoperative implant-site assessment. Panoramic radiographs are used immediately after surgery and at 4 months, with a 5-mm radiopaque calibration ball to correct for magnification. Bone width is calculated as ridge width minus buccal tissue thickness minus lingual or palatal tissue thickness. Data are entered into Microsoft Excel and analyzed using IBM SPSS Statistics. Continuous and categorical variables are summarized appropriately. Normality is assessed using the Shapiro-Wilk test and distribution plots. Between-group comparisons use one-way analysis of variance with an appropriate post hoc procedure for normally distributed outcomes or the Kruskal-Wallis test with adjusted pairwise comparisons for non-normal outcomes. Repeated observations are analyzed using a general linear model for repeated measures or the Friedman test, as appropriate. Statistical significance is set at p less than 0.05. The study protocol was reviewed and approved by the Research Ethics Committee of the College of Dentistry, Mustansiriyah University (approval No. MUOSU/POST-202609). Written informed consent is obtained from each participant before any study-related procedure.