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IRCT20210118050067N3 IRCT 2026-09-13 Esfahan University of Medical Sciences Design and evaluation of an alendronate-loaded chitosan membrane for bone regeneration in dental procedures, double-blind Randomized clinical trial Design and evaluation of an alendronate-loaded chitosan membrane for bone regeneration in dental procedures, double-blind Randomized clinical trial 2027-04-21 anticipated 20 Pending https://irct.ir/trial/90857 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is designed as a randomized, double-blind, split-mouth clinical trial. In each participant, two comparable sites (the right and left sides of the jaw or two anatomically similar intrabony periodontal defects) will be selected. One site will be randomly assigned to the test group, while the contralateral site will be assigned to the control group.Randomization will be performed at the site level rather than at the participant level. A computer-generated randomization sequence will be created using a randomization website or software. In this study, Randomized.org will be used for randomization. For each participant, the left and right treatment sites will be randomly allocated to either the treatment or placebo group. Thus, the participants themselves will not be randomized; rather, the treatment site (left or right side of the mouth) within each participant will be randomized, Blinding description: This study is designed as a randomized, split-mouth clinical trial. In each participant, two comparable sites (the right and left sides of the jaw or two anatomically similar intrabony periodontal defects) will be selected. One site will be randomly assigned to the test group, while the contralateral site will be assigned to the control group. Blinding will be implemented as follows. A third party who is not involved in the study (a dental assistant) will be responsible for maintaining the randomization schedule. According to the allocation list, the dental assistant will provide the treating clinician with either the alendronate-loaded collagen nanofiber or the placebo nanofiber. The two materials will be identical in appearance and therefore indistinguishable. The treating clinician, who is aware of the treatment allocation, will apply the assigned material to the corresponding treatment site. Subsequently, all clinical and radiographic data will be collected and analyzed by an independent outcome assessor (analyst), who may be a dental assistant and who is blinded to the treatment allocation and the study groups. The participants will also remain unaware of the treatment assigned to each site. Therefore, the participants and the outcome assessor will be blinded to the allocation, whereas the treating clinician will not be blinded and will be aware of the treatment assignment. 0 (exploratory trials) Bone regeneration in dental procedures. Intervention 1: Intervention group:The patient was comfortably seated in the dental chair and was instructed to rinse the mouth with 10 mL of 0.2% chlorhexidine digluconate solution. The surgical site was anesthetized using 2% lidocaine with epinephrine. Intrasulcular and interdental incisions were made on the buccal and lingual aspects using No. 12 and No. 15 periodontal blades, respectively. A full-thickness mucoperiosteal flap was carefully elevated, with particular attention paid to preserving the interdental papillary tissue as much as possible.After flap reflection and exposure of the osseous defects, thorough root planing was performed. The osseous defects were debrided using curettes, and the surgical site was thoroughly irrigated with normal saline. Subsequently, the bone graft material was applied to the defect area.In the test group, a chitosan nanofibrous membrane containing hydroxyapatite (HA), tricalcium phosphate (TCP), and alendronate was used. HA and TCP were incorporated at a ratio of 30:70, respectively, and alendronate was incorporated at a concentration of 10% w/w.Finally, the flap was repositioned without tension and sutured using a standard technique. The patients were instructed to rinse their mouths twice daily with 0.2% chlorhexidine digluconate mouthwash for 2 weeks. Postoperative instructions included avoiding hot foods, avoiding tooth brushing over the surgical dressing/site, and avoiding excessive or frequent mouth rinsing. Patients were also instructed to contact the clinic if any other problems or complications occurred.One week after surgery, the patients were recalled for suture removal and assessment of postoperative signs and symptoms. They were then instructed to continue chlorhexidine mouth rinsing for an additional week. Follow-up visits were scheduled at 2 weeks and at 1, 2, 3, and 6 months after surgery.At each follow-up visit, oral hygiene instructions were reinforced, and supragingival plaque was removed from the surgical sites. At 3 and 6 months postoperatively, the patients underwent clinical and radiographic evaluations of the test and control sites. Intervention 2: Control group:The patient was comfortably seated in the dental chair and was instructed to rinse the mouth with 10 mL of 0.2% chlorhexidine digluconate solution. The surgical site was anesthetized using 2% lidocaine with epinephrine. Intrasulcular and interdental incisions were made on the buccal and lingual aspects using No. 12 and No. 15 scalpel blades, respectively. A full-thickness mucoperiosteal flap was elevated, with care taken to preserve the interdental papillary tissue as much as possible.After flap reflection and exposure of the osseous defects, thorough root planing was performed. The osseous defects were debrided using curettes, and the surgical site was thoroughly irrigated with normal saline. Subsequently, bone graft material was applied to the defect area. In the control group, a similar chitosan nanofibrous membrane without the drug was used.Finally, the flap was repositioned without tension and sutured using a standard technique. The patients were instructed to rinse their mouths twice daily with 0.2% chlorhexidine digluconate mouthwash for 2 weeks. Postoperative instructions included avoiding hot foods, avoiding tooth brushing over the surgical dressing, and avoiding excessive or frequent mouth rinsing. The patients were also instructed to contact the clinic if any other problems or complications occurred.One week after surgery, the patients were recalled for suture removal and assessment of postoperative signs and symptoms. They were then instructed to continue chlorhexidine mouth rinsing for an additional week. Follow-up visits were scheduled at 2 weeks and at 1, 2, 3, and 6 months after surgery.At each follow-up visit, oral hygiene instructions were reinforced, and supragingival plaque was removed from the surgical sites. At 3 and 6 months postoperatively, the patients underwent clinical and radiographic evaluations of the test and control sites. No - There is not a plan to make this available Justification or reason for not sharing IPD is Protection of patient privacy
public Dr Prisa Ranjbarian
School of Dentistry, Islamic Azad University, Isfahan (Khorasgan) Branch, Imam Reza Boulevard, Morvarid Street, between Valiasr Boulevard and Dr. Ahmad Ali Foroughi Street, Arghavaniyeh District, Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8155139998 +98 31 3535 0019 p.ranjbarian@iau.ac.ir School of Dentistry, Islamic Azad University, Isfahan (Khorasgan) Branch, Isfahan, Iran scientific Dr Parisa ranjbarian
School of Dentistry, Islamic Azad University, Isfahan (Khorasgan) Branch, Imam Reza Boulevard, Morvarid Street, between Valiasr Boulevard and Dr. Ahmad Ali Foroughi Street, Arghavaniyeh District, Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8155139998 +98 31 3535 0019 p.ranjbarian@iau.ac.ir Islamic Azad University Iran (Islamic Republic of) Age between 25 and 55 years. Good general health status (ASA I or ASA II) according to the American Society of Anesthesiologists (ASA) classification criteria No use of medications affecting bone healing (e.g., bisphosphonates or corticosteroids) No antibiotic use within the past three months.5. Non-smoker or smoking fewer than 5 cigarettes per day Non-smoker or smoking fewer than 5 cigarettes per day Availability of an appropriate pre-treatment CBCT scan for evaluation of the location of bone defects. Presence of two intrabony periodontal defects with a depth of ≥ 5 mm and similar morphology. 25 years 55 years Both Receipt of periodontal treatment within the previous 6 months. Pregnancy or lactation Uncontrolled systemic diseases. Active infection at the surgical site Treatment - Drugs Placebo Intervention group:The patient was comfortably seated in the dental chair and was instructed to rinse the mouth with 10 mL of 0.2% chlorhexidine digluconate solution. The surgical site was anesthetized using 2% lidocaine with epinephrine. Intrasulcular and interdental incisions were made on the buccal and lingual aspects using No. 12 and No. 15 periodontal blades, respectively. A full-thickness mucoperiosteal flap was carefully elevated, with particular attention paid to preserving the interdental papillary tissue as much as possible.After flap reflection and exposure of the osseous defects, thorough root planing was performed. The osseous defects were debrided using curettes, and the surgical site was thoroughly irrigated with normal saline. Subsequently, the bone graft material was applied to the defect area.In the test group, a chitosan nanofibrous membrane containing hydroxyapatite (HA), tricalcium phosphate (TCP), and alendronate was used. HA and TCP were incorporated at a ratio of 30:70, respectively, and alendronate was incorporated at a concentration of 10% w/w.Finally, the flap was repositioned without tension and sutured using a standard technique. The patients were instructed to rinse their mouths twice daily with 0.2% chlorhexidine digluconate mouthwash for 2 weeks. Postoperative instructions included avoiding hot foods, avoiding tooth brushing over the surgical dressing/site, and avoiding excessive or frequent mouth rinsing. Patients were also instructed to contact the clinic if any other problems or complications occurred.One week after surgery, the patients were recalled for suture removal and assessment of postoperative signs and symptoms. They were then instructed to continue chlorhexidine mouth rinsing for an additional week. Follow-up visits were scheduled at 2 weeks and at 1, 2, 3, and 6 months after surgery.At each follow-up visit, oral hygiene instructions were reinforced, and supragingival plaque was removed from the surgical sites. At 3 and 6 months postoperatively, the patients underwent clinical and radiographic evaluations of the test and control sites. Control group:The patient was comfortably seated in the dental chair and was instructed to rinse the mouth with 10 mL of 0.2% chlorhexidine digluconate solution. The surgical site was anesthetized using 2% lidocaine with epinephrine. Intrasulcular and interdental incisions were made on the buccal and lingual aspects using No. 12 and No. 15 scalpel blades, respectively. A full-thickness mucoperiosteal flap was elevated, with care taken to preserve the interdental papillary tissue as much as possible.After flap reflection and exposure of the osseous defects, thorough root planing was performed. The osseous defects were debrided using curettes, and the surgical site was thoroughly irrigated with normal saline. Subsequently, bone graft material was applied to the defect area. In the control group, a similar chitosan nanofibrous membrane without the drug was used.Finally, the flap was repositioned without tension and sutured using a standard technique. The patients were instructed to rinse their mouths twice daily with 0.2% chlorhexidine digluconate mouthwash for 2 weeks. Postoperative instructions included avoiding hot foods, avoiding tooth brushing over the surgical dressing, and avoiding excessive or frequent mouth rinsing. The patients were also instructed to contact the clinic if any other problems or complications occurred.One week after surgery, the patients were recalled for suture removal and assessment of postoperative signs and symptoms. They were then instructed to continue chlorhexidine mouth rinsing for an additional week. Follow-up visits were scheduled at 2 weeks and at 1, 2, 3, and 6 months after surgery.At each follow-up visit, oral hygiene instructions were reinforced, and supragingival plaque was removed from the surgical sites. At 3 and 6 months postoperatively, the patients underwent clinical and radiographic evaluations of the test and control sites. Measurement of probing pocket depth (PPD). Timepoint: Before the intervention and at 1, 3, and 6 months post-intervention. Method of measurement: Dental radiography. Clinical Attachment Level (CAL). Timepoint: Before the intervention and at 1, 3, and 6 months post-intervention. Method of measurement: Dental radiography. Bleeding on Probing (BOP). Timepoint: At the time of intervention. Method of measurement: Clinical assessment. Change in Bone Height. Timepoint: Before the intervention and at 1, 3, and 6 months post-intervention. Method of measurement: Dental radiography. Esfahan University of Medical Sciences Approved 2026-06-09 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)