Tooth Extraction Status NosPhase 2NCT06140277
Using Of Chitosan in Alveolar Ridge Preservation
A Phase 2 study testing extraction with chitosan particles as a replacement for bone graft with collagen membrane, extraction with placing of allograft particles with collagen membrane and tooth extraction only in people with Tooth Extraction Status Nos and Bone Augmentation, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to assess the efficacy of chitosan as a socket preservation material after tooth extraction in compare to the standard treatment. The study will include patients who exhibit hopeless tooth without any periodontal infection. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction Status Nos, Bone Augmentation
- What is being tested?
- extraction with chitosan particles as a replacement for bone graft with collagen membrane, extraction with placing of allograft particles with collagen membrane and tooth extraction only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 18 Jan 2023to 20 Mar 2024
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of hopeless tooth.
- Healthy patient.
- Healthy gingiva without any periodontal disease.
- Patient is welling to come after three months.
Who cannot join
- Smokers.
- History of allergy.
- pregnant women.
- patient with systemic disease.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Prince Sattam Bin Abdulaziz University
Riyadh, Central, 16273
About this study
Official title: Using Of Chitosan in Alveolar Ridge Preservation: Randomized Clinical Trial.
The goal of this clinical trial is to assess the efficacy of chitosan as a socket preservation material after tooth extraction in compare to the standard treatment. The study will include patients who exhibit hopeless tooth without any periodontal infection. Smokers, history of allergy, patients with major medical issue and pregnant women will be excluded from the study. The main question[s] to answer is : is there a significant difference in bone density and dimension between the test and control groups after tooth extraction or not.
Participants will be asked to do CBCT scan and take upper and lower impressions before extraction and after three month from extraction. Then, the patients will randomly assigned to one from these groups: There will be a total of three groups (10 patients for each), first group will be treated using mixed of chitosan and allograft, second group will be treated using allograft alone and the last group will be used as control. All patients will be treated in accordance with the 2013 Declaration of Helsinki.
Read the detailed description
To evaluate the tissue response, intraoral impressions and X-ray will be taking from each patient before extraction and three months after. Also, Cone-beam computed tomography (CBCT) will be taking to measure the bone growth at base line and three months after surgery is done. For measurement, each socket will be vertically divided into 3 equal areas: coronal, middle, and apical. Regenerated bone density will be assessed in each area, in both control and intervention groups.
Data then can be analyzed using SPSS ver. 11 (SPSS Inc., Chicago,USA). P-values less than 0.05 were considered as significant.
- Conditions
- Tooth Extraction Status Nos, Bone Augmentation
- Being tested
- extraction with chitosan particles as a replacement for bone graft with collagen membrane, extraction with placing of allograft particles with collagen membrane, tooth extraction only
- Keywords
- chitosan, socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extraction with chitosan particles as a replacement for bone graft with collagen membraneProcedure or surgery
Also called chitosan
to replace the bone at the extraction site we will put either chitosan or allograft particles
extraction with placing of allograft particles with collagen membraneProcedure or surgery
Also called gold standard treatment
to replace the bone at the extraction site we will put allograft particles
tooth extraction onlyProcedure or surgery
Also called normal extraction
hopeless tooth will be extracted without any intervention
| Study group | Role | What they receive |
|---|---|---|
| Chitosan | Experimental | group will be treated using chitosan as a replacement of bone particles with collagen membrane after tooth extraction Receives: Procedure: extraction with chitosan particles as a replacement for bone graft with collagen membrane |
| Allograft | Active comparator | after extraction, the group will be treated using the gold standard protocol which is the (allograft) bone particles with collagen membrane. Receives: Procedure: extraction with placing of allograft particles with collagen membrane |
| placebo | Placebo comparator | the extraction will be done without placing any bone material inside Receives: Procedure: tooth extraction only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Hight
Changes in vertical dimension in mm from baseline using scans section from CBCT.
Measured: 3 months
Bone volume
Changes in horizontal width in mm from baseline using scans section from CBCT.
Measured: 3 months
Secondary outcomes (2)
Tissue healing
changes in scale of redness of gingiva from baseline
Measured: 3 months
Dry socket
the No of exposed bone from baseline until healing
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Jan 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion20 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Status NosStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be a total of 3 groups (10 patients for each), first group will be treated using chitosan as a replacement of bone particles with collagen membrane. 2nd group will be treated using the gold standard protocol which is the allograft bone particles with collagen membrane, and the last group will received nothing as control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140277
- Sponsor's protocol ID
- PrinceSBAU
- Status last verified
- Nov 2023
- First submitted
- 9 Jul 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Of Chitosan in Alveolar Ridge Preservation: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06140277
- Acronym / sponsor ID
- PrinceSBAU
- Conditions
- Tooth Extraction Status Nos, Bone Augmentation
- Keywords
- chitosan, socket preservation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 20 Mar 2024 (estimated)
- First posted
- 18 Nov 2023 (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 goal of this clinical trial is to assess the efficacy of chitosan as a socket preservation material after tooth extraction in compare to the standard treatment. The study will include patients who exhibit hopeless tooth without any periodontal infection. Smokers, history of allergy, patients with major medical issue and pregnant women will be excluded from the study. The main question[s] to answer is : is there a significant difference in bone density and dimension between the test and control groups after tooth extraction or not.
Participants will be asked to do CBCT scan and take upper and lower impressions before extraction and after three month from extraction. Then, the patients will randomly assigned to one from these groups: There will be a total of three groups (10 patients for each), first group will be treated using mixed of chitosan and allograft, second group will be treated using allograft alone and the last group will be used as control. All patients will be treated in accordance with the 2013 Declaration of Helsinki.
Detailed description
To evaluate the tissue response, intraoral impressions and X-ray will be taking from each patient before extraction and three months after. Also, Cone-beam computed tomography (CBCT) will be taking to measure the bone growth at base line and three months after surgery is done. For measurement, each socket will be vertically divided into 3 equal areas: coronal, middle, and apical. Regenerated bone density will be assessed in each area, in both control and intervention groups.
Data then can be analyzed using SPSS ver. 11 (SPSS Inc., Chicago,USA). P-values less than 0.05 were considered as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- There will be a total of 3 groups (10 patients for each), first group will be treated using chitosan as a replacement of bone particles with collagen membrane. 2nd group will be treated using the gold standard protocol which is the allograft bone particles with collagen membrane, and the last group will received nothing as control
| Arm | Type | Receives |
|---|---|---|
| Chitosan | Experimental | Procedure: extraction with chitosan particles as a replacement for bone graft with collagen membranegroup will be treated using chitosan as a replacement of bone particles with collagen membrane after tooth extraction |
| Allograft | Active comparator | Procedure: extraction with placing of allograft particles with collagen membraneafter extraction, the group will be treated using the gold standard protocol which is the (allograft) bone particles with collagen membrane. |
| placebo | Placebo comparator | Procedure: tooth extraction onlythe extraction will be done without placing any bone material inside |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of hopeless tooth.
- Healthy patient.
- Healthy gingiva without any periodontal disease.
- Patient is welling to come after three months.
Key exclusion criteria (4 listed)
- Smokers.
- History of allergy.
- pregnant women.
- patient with systemic disease.
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 |
|---|---|---|
| extraction with chitosan particles as a replacement for bone graft with collagen membraneAlso: chitosanto replace the bone at the extraction site we will put either chitosan or allograft particles | Procedure or surgery | Chitosan |
| extraction with placing of allograft particles with collagen membraneAlso: gold standard treatmentto replace the bone at the extraction site we will put allograft particles | Procedure or surgery | Allograft |
| tooth extraction onlyAlso: normal extractionhopeless tooth will be extracted without any intervention | Procedure or surgery | placebo |
Primary outcome
Bone Hight
Time frame: 3 months
Changes in vertical dimension in mm from baseline using scans section from CBCT.
Bone volume
Time frame: 3 months
Changes in horizontal width in mm from baseline using scans section from CBCT.
2 secondary outcomes
Tissue healing
Time frame: 3 months
Dry socket
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Related trials for Tooth Extraction Status Nos
Active, not recruiting
Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
Facial Swelling, Tooth Position Anomalies
Recruiting
Assessment of Labial Plate Thickness After Immediate Implant Placement Using Two Different Xenografts in the Esthetic Zone
Alveolar Bone Loss, Tooth Extraction Status Nos
Recruiting
Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar
Tooth Disease, Piezoelectric Technique
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 Phase 2 study testing extraction with chitosan particles as a replacement for bone graft with collagen membrane, extraction with placing of allograft particles with collagen membrane and tooth extraction only in people with Tooth Extraction Status Nos and Bone Augmentation, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Bone Hight (time frame: 3 months). The study lists 2 primary outcomes in all. 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 Nov 2023.