Implant ComplicationNCT05776290
The Effect of Hyaluronic Acid Gel on Relieving Post-Implantation Pain
A study testing Hyaluronic Acid in people with Implant Complication, run by Damascus University at 1 site in Syria.
Trial summary
Few previous studies have employed HA in the implant socket; instead, the majority have applied it topically to the area around dental implants after they have been placed. The application was done after suturing in these investigations. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Implant Complication
- What is being tested?
- Hyaluronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSyria
- Study dates
- 15 Feb 2021to 15 May 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- bilateral tooth loss with a sufficient amount of bone volume
- no general problems
- good oral health
- age between 20 and 60 years
Who cannot join
- the use of immunosuppressive drugs and corticosteroids for long periods
- the existence of serious systemic disorders
- contraindications for local anesthesia or oral surgery
- pregnant women and nursing mothers
- patients receiving chemotherapy or radiation
- alcoholics and heavy smokers.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Oral Medicine, Faculty of Dentistry, University of Damascus
Damascus, DM20AM19
About this study
Official title: Evaluation of the Efficacy of a Hyaluronic Acid Gel in Relieving Post-Implantation Pain: A Split-Mouth Randomized Controlled Trial
Few previous studies have employed HA in the implant socket; instead, the majority have applied it topically to the area around dental implants after they have been placed. The application was done after suturing in these investigations. Therefore, the goal of the current study was to inject HA into the implant socket and onto the alveolar bone prior to implant insertion and suturing in order to preserve the HA for an extended period of time.
This study aims to use a visual analog scale (VAS) on the first, third, and tenth days following the surgical intervention to assess the efficacy of employing HA in dental implants in terms of pain reduction that may accompany dental implant surgery.
- Conditions
- Implant Complication
- Being tested
- Hyaluronic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidBiological
This material will be injected into the prepared impact socket prior to inserting the implant. This injection will be done inside the socket as well as on the periphery of the socket.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid injection | Experimental | The hyaluronic acid will be injected into the implant socket before implantation. Receives: Biological: Hyaluronic Acid |
| Traditional treatment | No intervention | The socket will be prepared in the normal manner without being injected with any material. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Perception of pain
This will be measured using a numeric rating scale. Patients will be asked to indicate the level of pain they perceive on a scale from 1 to 10. The intensity of pain is going to be classified according to the following categories: 0 = no pain, 1-3 = mild pain, 3-6 = moderate pain, and 6-10 = severe pain.
Measured: First assessment: at 24 hours following the surgical procedure. Second assessment: at 72 hours following the surgical intervention. Third assessment will be made on the tenth day following the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start15 Feb 2021
- Primary completion15 Mar 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies 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
- Model description
- Split mouth design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waseem Al-Khateeb, DDS MSc, Principal investigator, PhD student at the Department of Oral Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776290
- Sponsor's protocol ID
- UDDS-OralMed-01-2023
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Datasets and the underlying worksheets are available upon reasonable request from the corresponding author once the paper has been published.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Hyaluronic Acid Gel in Relieving Post-Implantation Pain: A Split-Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05776290
- Acronym / sponsor ID
- UDDS-OralMed-01-2023
- Conditions
- Implant Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 20 Mar 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.
Few previous studies have employed HA in the implant socket; instead, the majority have applied it topically to the area around dental implants after they have been placed. The application was done after suturing in these investigations. Therefore, the goal of the current study was to inject HA into the implant socket and onto the alveolar bone prior to implant insertion and suturing in order to preserve the HA for an extended period of time.
This study aims to use a visual analog scale (VAS) on the first, third, and tenth days following the surgical intervention to assess the efficacy of employing HA in dental implants in terms of pain reduction that may accompany dental implant surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth design
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid injection | Experimental | Biological: Hyaluronic AcidThe hyaluronic acid will be injected into the implant socket before implantation. |
| Traditional treatment | No intervention | –The socket will be prepared in the normal manner without being injected with any material. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- bilateral tooth loss with a sufficient amount of bone volume
- no general problems
- good oral health
- age between 20 and 60 years
Key exclusion criteria (6 listed)
- the use of immunosuppressive drugs and corticosteroids for long periods
- the existence of serious systemic disorders
- contraindications for local anesthesia or oral surgery
- pregnant women and nursing mothers
- patients receiving chemotherapy or radiation
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 will be injected into the prepared impact socket prior to inserting the implant. This injection will be done inside the socket as well as on the periphery of the socket. | Biological | Hyaluronic acid injection |
Primary outcome
Change in the Perception of pain
Time frame: First assessment: at 24 hours following the surgical procedure. Second assessment: at 72 hours following the surgical intervention. Third assessment will be made on the tenth day following the surgical intervention
This will be measured using a numeric rating scale. Patients will be asked to indicate the level of pain they perceive on a scale from 1 to 10. The intensity of pain is going to be classified according to the following categories: 0 = no pain, 1-3 = mild pain, 3-6 = moderate pain, and 6-10 = severe pain.
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 7 Apr 2023.
- Individual participant dataSharing planned: No. Datasets and the underlying worksheets are available upon reasonable request from the corresponding author once the paper has been published.
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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.
Waseem Al-Khateeb, DDS MSc principal investigator
PhD student at the Department of Oral Medicine
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 Implant Complication, 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 4 inclusion and 6 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 7 Apr 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 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 the Perception of pain (time frame: First assessment: at 24 hours following the surgical procedure. Second assessment: at 72 hours following the surgical intervention. Third assessment will be made on the tenth day following the surgical intervention). 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 7 Apr 2023.