Patients With Dental ExtractionNCT02330822
Role of Hyaluronic Acid in Bone Healing After Dental Extraction
A study testing Hyaluronic Acid in people with Patients With Dental Extraction, run by Damascus University at 1 site in Syria.
Trial summary
This is a randomized controlled trial with a split mouth design. Patients with an indication of lower dental extraction will be asked to join this research project at the Department of Oral and Maxillofacial Surgery at University of Damascus Dental School. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Dental Extraction
- What is being tested?
- Hyaluronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- Dec 2014to Sep 2015
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years old
- Symmetric teeth requiring extraction in the lower jaw
- Systematically healthy
Who cannot join
- Smokers
- Pregnancy (for female participants)
- Diabetic patients
- Patients with metabolic problems
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
Damascus, Damscus, DM20AM18
About this study
Official title: A Clinical and Experimental Study to Evaluate the Efficacy of Locally Applied Hyaluronic Acid in Bone Healing Following Dental Extraction
This is a randomized controlled trial with a split mouth design. Patients with an indication of lower dental extraction will be asked to join this research project at the Department of Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose case requires bilateral extraction, one side will serve as an experimental side, whereas the other side will serve as a control.
Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic acid will be injected following extraction in one of the two sides with random allocation.
cone-beam computerized tomography (CBCT) images will be taken for each participant immediately post-extraction and at six months post-operatively.
Read the detailed description
I- Clinical examination variables:
Buccolingual distance and distomesial distance will be measured for each participant at 2 assessment times: directly post-extraction and six months post-extraction.
II- Radiographic examination variables:
Linear measurements Vertical bone fill Bone mineral density
- Conditions
- Patients With Dental Extraction
- Being tested
- Hyaluronic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
This material is going to be injected into the extraction socket in order to promote bone healing.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid Group | Experimental | In this Group, Hyaluronic acid will be injected following extraction. Receives: Drug: Hyaluronic Acid |
| Traditional Extraction Group | No intervention | In this group, traditional extraction procedures will be followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone mineral density (BMD)
BMD is the amount of bone tissue in a certain volume of bone. This variable is going to be measured on CBCT images.
Measured: (BMD) will be measured two times in this study: directly at the day of extraction and six months post-extraction.
Vertical bone fill
'Vertical bone fill' is the distance between the base of the extraction socket and cement-enamel junction directly after extraction and minus the distance between base of the extraction socket and cement-enamel junction six months post-extraction.
This variable is going to be measured on CBCT images.
Measured: This variable is going to be measured at 6 months post-extraction
Secondary outcomes (2)
Buccolingual distance
Buccolingual distance is the distance between buccal wall and lingual wall of the extraction socket. This variable is going to be measured clinically.
Measured: at six months post-extraction
Mesiodistal distance
Mesiodistal distance is the distance between mesial wall and distal wall of the extraction socket. This variable is going to be measured clinically.
Measured: at six months post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With Dental ExtractionStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sireen Abu Atta, DDS MSc, Principal investigator, PhD student, Department of Oral and Maxillofacial Surgery, University of Damascus Dental SchoolMazen Zenati, DDS MSc PhD, Study director, Professor of Oral and Maxillofacial Surgery, University of Damsacus Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330822
- Sponsor's protocol ID
- UDDS-OMFS-01-2015
- Status last verified
- Sep 2015
- First submitted
- 1 Jan 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baldini A, Zaffe D, Nicolini G. Bone-defects healing by high-molecular hyaluronic acid: preliminary results. Ann Stomatol (Roma). 2010 Jan;1(1):2-7. Epub 2010 Jun 29.
PubMed 22238698Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.
PubMed 15842256de Brito Bezerra B, Mendes Brazao MA, de Campos ML, Casati MZ, Sallum EA, Sallum AW. Association of hyaluronic acid with a collagen scaffold may improve bone healing in critical-size bone defects. Clin Oral Implants Res. 2012 Aug;23(8):938-42. doi: 10.1111/j.1600-0501.2011.02234.x. Epub 2011 Jun 21.
PubMed 21689163
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical and Experimental Study to Evaluate the Efficacy of Locally Applied Hyaluronic Acid in Bone Healing Following Dental Extraction
- ClinicalTrials.gov ID
- NCT02330822
- Acronym / sponsor ID
- UDDS-OMFS-01-2015
- Conditions
- Patients With Dental Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Jan 2015 (estimated)
- 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.
This is a randomized controlled trial with a split mouth design. Patients with an indication of lower dental extraction will be asked to join this research project at the Department of Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose case requires bilateral extraction, one side will serve as an experimental side, whereas the other side will serve as a control.
Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic acid will be injected following extraction in one of the two sides with random allocation.
cone-beam computerized tomography (CBCT) images will be taken for each participant immediately post-extraction and at six months post-operatively.
Detailed description
I- Clinical examination variables:
Buccolingual distance and distomesial distance will be measured for each participant at 2 assessment times: directly post-extraction and six months post-extraction.
II- Radiographic examination variables:
Linear measurements Vertical bone fill Bone mineral density
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid Group | Experimental | Drug: Hyaluronic AcidIn this Group, Hyaluronic acid will be injected following extraction. |
| Traditional Extraction Group | No intervention | –In this group, traditional extraction procedures will be followed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years old
- Symmetric teeth requiring extraction in the lower jaw
- Systematically healthy
Key exclusion criteria (4 listed)
- Smokers
- Pregnancy (for female participants)
- Diabetic patients
- Patients with metabolic problems
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 |
|---|---|---|
| Hyaluronic AcidThis material is going to be injected into the extraction socket in order to promote bone healing. | Drug | Hyaluronic Acid Group |
Primary outcome
Change in bone mineral density (BMD)
Time frame: (BMD) will be measured two times in this study: directly at the day of extraction and six months post-extraction.
BMD is the amount of bone tissue in a certain volume of bone. This variable is going to be measured on CBCT images.
Vertical bone fill
Time frame: This variable is going to be measured at 6 months post-extraction
'Vertical bone fill' is the distance between the base of the extraction socket and cement-enamel junction directly after extraction and minus the distance between base of the extraction socket and cement-enamel junction six months post-extraction. This variable is going to be measured on CBCT images.
2 secondary outcomes
Buccolingual distance
Time frame: at six months post-extraction
Mesiodistal distance
Time frame: at six months post-extraction
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 29 Sep 2015.
- Background: PubMed 22238698Baldini A, Zaffe D, Nicolini G. Bone-defects healing by high-molecular hyaluronic acid: preliminary results. Ann Stomatol (Roma). 2010 Jan;1(1):2-7. Epub 2010 Jun 29.
- Background: PubMed 15842256Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.
- Background: PubMed 21689163de Brito Bezerra B, Mendes Brazao MA, de Campos ML, Casati MZ, Sallum EA, Sallum AW. Association of hyaluronic acid with a collagen scaffold may improve bone healing in critical-size bone defects. Clin Oral Implants Res. 2012 Aug;23(8):938-42. doi: 10.1111/j.1600-0501.2011.02234.x. Epub 2011 Jun 21.
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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.
Sireen Abu Atta, DDS MSc principal investigator
PhD student, Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
Mazen Zenati, DDS MSc PhD study director
Professor of Oral and Maxillofacial Surgery, University of Damsacus Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid in people with Patients With Dental Extraction, run by Damascus University at 1 site in Syria.
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 29 Sep 2015. 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 Syria. 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?
Change in bone mineral density (BMD) (time frame: (BMD) will be measured two times in this study: directly at the day of extraction and six months post-extraction.). 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?
On the ClinicalTrials.gov record for NCT02330822, which also lists 3 linked publications.
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 29 Sep 2015.