ChitosanNCT06373757
Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect
A study testing Nano-HAP/Chitosan hydrogel in people with Chitosan and Nano-hydroxyapatite Hydrogel, run by October 6 University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chitosan, Nano-hydroxyapatite Hydrogel, Intrabony Defect
- What is being tested?
- Nano-HAP/Chitosan hydrogel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 25 to 55 years.
- Both sexes.
- Patients with stage II to III periodontitis with probing pocket depths ≥ 5 mm and radiographic evidence showing infrabony defect.
Who cannot join
- Patients received periodontal or antibiotic therapy within the previous 6 months preceding the study.
- Smokers.
- Pregnant and lactating females.
- Patients on medications known to affect bone turnover or with known side effects to chitosan, nano-hydroxyapatite, and collagen membrane.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect (Randomized Clinical Trial)
The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects.
Read the detailed description
Periodontitis is a chronic inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the connective tissue attachment of the teeth.
Treatment modalities of periodontitis includes local drug delivery such as chitosan which is a derivative of the exoskeleton of many arthropods including prawns, lobsters and crabs.
Chitosan has been used in guided bone regeneration, hemostasis of surgical wounds, and coating of dental implants, in reconstruction of temporomandibular joint disc and guided periodontal tissue regeneration. Moreover, chitosan has been used for preventing demineralization.
HA also called hydroxylapatite, is a naturally occurring mineral form of calcium apatite with the formula Ca5(PO4)3(OH). The OH- ion can be replaced by fluoride, and carbonate, producing fluorapatite or chlorapatite. It crystallizes in the hexagonal crystal system.
- Conditions
- Chitosan, Nano-hydroxyapatite Hydrogel, Intrabony Defect
- Being tested
- Nano-HAP/Chitosan hydrogel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-HAP/Chitosan hydrogelOther
The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place.
| Study group | Role | What they receive |
|---|---|---|
| Group I (nano-HAP/Chitosan hydrogel): | Experimental | The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place. Receives: Other: Nano-HAP/Chitosan hydrogel |
| Group II | No intervention | Patients were treated with supra and sub-gingival debridement only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index
Gingival index (GI) used for the assessment of prevalence and severity of gingivitis. A score from 0 to 3 is given to each area of the tooth.0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
It was evaluated for every patient included in the study, 3 and at 6 months after treatment.
Measured: 6 months after treatment
Secondary outcomes (4)
Plaque index
Plaque index (PI) was used to assess oral hygiene where 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.
It was evaluated for every patient included in the study, 3 and at 6 months after treatment.
Measured: 6 months after treatment
Clinical attachment level
Clinical attachment level (CAL) was evaluated for every patient included in the study, 3 and at 6 months after treatment.
Measured: 6 months after treatment
Periodontal probing depth
Periodontal probing depth (PD) (referred to as pocket depth if periodontal disease is present) is the distance from the gingival margin to the apical portion of the gingival sulcus. Probing depths in healthy gingival sulci normally range from 1 to 3 mm.
It was evaluated for every patient included in the study, 3 and at 6 months after treatment.
Measured: 6 months after treatment
Acrylic stent for pocket assessment
Acrylic stent for pocket assessment was evaluated for every patient included in the study, 3 and at 6 months after treatment.
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Mar 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChitosanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Ahmed Mohamed Alaraby, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373757
- Sponsor's protocol ID
- RECO6U/5-2023
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06373757
- Acronym / sponsor ID
- RECO6U/5-2023
- Conditions
- Chitosan, Nano-hydroxyapatite Hydrogel, Intrabony Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects.
Detailed description
Periodontitis is a chronic inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the connective tissue attachment of the teeth.
Treatment modalities of periodontitis includes local drug delivery such as chitosan which is a derivative of the exoskeleton of many arthropods including prawns, lobsters and crabs.
Chitosan has been used in guided bone regeneration, hemostasis of surgical wounds, and coating of dental implants, in reconstruction of temporomandibular joint disc and guided periodontal tissue regeneration. Moreover, chitosan has been used for preventing demineralization.
HA also called hydroxylapatite, is a naturally occurring mineral form of calcium apatite with the formula Ca5(PO4)3(OH). The OH- ion can be replaced by fluoride, and carbonate, producing fluorapatite or chlorapatite. It crystallizes in the hexagonal crystal system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (nano-HAP/Chitosan hydrogel): | Experimental | Other: Nano-HAP/Chitosan hydrogelThe periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place. |
| Group II | No intervention | –Patients were treated with supra and sub-gingival debridement only. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 25 to 55 years.
- Both sexes.
- Patients with stage II to III periodontitis with probing pocket depths ≥ 5 mm and radiographic evidence showing infrabony defect.
Key exclusion criteria (4 listed)
- Patients received periodontal or antibiotic therapy within the previous 6 months preceding the study.
- Smokers.
- Pregnant and lactating females.
- Patients on medications known to affect bone turnover or with known side effects to chitosan, nano-hydroxyapatite, and collagen membrane.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano-HAP/Chitosan hydrogelThe periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place. | Other | Group I (nano-HAP/Chitosan hydrogel): |
Primary outcome
Gingival index
Time frame: 6 months after treatment
Gingival index (GI) used for the assessment of prevalence and severity of gingivitis. A score from 0 to 3 is given to each area of the tooth.0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation. It was evaluated for every patient included in the study, 3 and at 6 months after treatment.
4 secondary outcomes
Plaque index
Time frame: 6 months after treatment
Clinical attachment level
Time frame: 6 months after treatment
Periodontal probing depth
Time frame: 6 months after treatment
Acrylic stent for pocket assessment
Time frame: 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-HAP/Chitosan hydrogel in people with Chitosan and Nano-hydroxyapatite Hydrogel, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival index (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.