Fabrication and evaluation of alendronate-loaded chitosan nanofibers.
Design
This study is a Phase II randomized, double-blind, controlled clinical trial with parallel groups, conducted on 20 patients.
Settings and conduct
This study involves periodontal surgery and will be conducted at the Dental School of the Islamic Azad university Khorasgan.
Participants/Inclusion and exclusion criteria
Inclusion criteria were as follows: age between 25 and 55 years; good general health (ASA physical status I or II according to the American Society of Anesthesiologists [ASA] classification); no use of medications affecting bone healing (e.g., bisphosphonates or corticosteroids); no antibiotic use within the previous 3 months; non-smokers or individuals smoking fewer than five cigarettes per day; availability of a preoperative cone-beam computed tomography (CBCT) scan suitable for evaluating the location of intrabony defects; and the presence of two intrabony periodontal defects with a probing depth of ≥ 5 mm and similar morphology.
Exclusion criteria included a history of periodontal treatment within the previous 6 months, pregnancy or lactation, uncontrolled systemic diseases, active infection at the surgical site
Intervention groups
The study consisted of two intervention groups. The treatment group received the fabricated collagen nanofibers loaded with alendronate, whereas the placebo group received collagen nanofibers with identical physical and structural characteristics but without alendronate.
Main outcome variables
Probing Pocket Depth (PPD/PD) ; Clinical Attachment Level (CAL) ; Bleeding on Probing (BOP) ; Change in Bone Height
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210118050067N3
Registration date:2026-09-13, 1405/06/22
Registration timing:prospective
Last update:2026-09-13, 1405/06/22
Update count:0
Registration date
2026-09-13, 1405/06/22
Registrant information
Name
Erfaneh Ghassami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7118
Email address
e.ghassami@pharm.mui.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2027-04-21, 1406/02/01
Expected recruitment end date
2027-10-23, 1406/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation of an alendronate-loaded chitosan membrane for bone regeneration in dental procedures, double-blind Randomized clinical trial
Public title
Design and evaluation of an alendronate-loaded chitosan membrane for bone regeneration in dental procedures, double-blind Randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
Receipt of periodontal treatment within the previous 6 months.
Pregnancy or lactation
Uncontrolled systemic diseases.
Active infection at the surgical site
Age
From 25 years old to 55 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2026-06-09, 1405/03/19
Ethics committee reference number
IR.MUI.PHANUT.REC.1405.049
Health conditions studied
1
Description of health condition studied
Bone regeneration in dental procedures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of probing pocket depth (PPD)
Timepoint
Before the intervention and at 1, 3, and 6 months post-intervention
Method of measurement
Dental radiography
2
Description
Clinical Attachment Level (CAL)
Timepoint
Before the intervention and at 1, 3, and 6 months post-intervention
Method of measurement
Dental radiography
3
Description
Bleeding on Probing (BOP)
Timepoint
At the time of intervention
Method of measurement
Clinical assessment
4
Description
Change in Bone Height
Timepoint
Before the intervention and at 1, 3, and 6 months post-intervention
Method of measurement
Dental radiography
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Islamic Azad University, Khorasgan Branch, Isfahan, Iran
Full name of responsible person
Dr Ehsan rafii
Street address
Imam Reza Boulevard, Morvarid Street, between Valiasr Boulevard and Dr. Ahmad Ali Foroughi Street, Arghavaniyeh District, Islamic Azad University, Isfahan (Khorasgan) Branch, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 913 318 2508
Email
ehsanrafiei@iau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Erfaneh Ghassami
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
e.ghassami@pharm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
School of Dentistry, Islamic Azad University, Isfahan (Khorasgan) Branch, Isfahan, Iran
Full name of responsible person
Dr Prisa Ranjbarian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
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.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 0019
Email
p.ranjbarian@iau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Parisa ranjbarian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
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.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 0019
Email
p.ranjbarian@iau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Parisa Ranjbarian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
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.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 0019
Email
p.ranjbarian@iau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Protection of patient privacy
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The study protocol and the statistical analysis plan will be detailed in the final manuscript
When the data will become available and for how long
At all times
To whom data/document is available
everyone
Under which criteria data/document could be used
The intellectual property rights associated with the study data are owned by the research team. Any use, reproduction, or publication of these data is permitted only with proper acknowledgment and citation of the original source.
From where data/document is obtainable
Refer to the article
What processes are involved for a request to access data/document