Missing TeethNCT05403099
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
A study testing Hyaluronic acid and conventional implant placement in people with Missing Teeth, run by Mansoura University at 1 site in Egypt.
Trial summary
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Hyaluronic acid and conventional implant placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Mar 2020
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Highly motivated patients with good oral hygiene.
- Age 18 years or older.
- Adequate alveolar bone volume at the implant site, at least 6mm in width and 15 mm in height.
- Free from any parafunctional habits
Who cannot join
- Patients suffering from any systemic or local disease that contraindicate implant placement or surgery.
- Pregnancy.
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Read the detailed description
Patients were randomly divided into two groups:
Group I (Control group):
Ten implants were placed in posterior maxilla and immediately loaded.
Group II (Study group):
Ten implants were coated with HA before placement in posterior maxilla and immediately loaded.
- Conditions
- Missing Teeth
- Being tested
- Hyaluronic acid, conventional implant placement
- Keywords
- Hyaluronic Acid, dental implant
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidOther
immediate placement of dental implant after topical application of hyaluronic acid on implant surface
conventional implant placementOther
immediate placement of dental implant without application of hyaluronic acid on implant surface
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Each implant was placed into the prepared implant site. Receives: Other: conventional implant placement |
| Hyaluronic acid | Experimental | Each implant was placed after topical application of HA on its surface Receives: Other: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
using radiofrequency analysis
Measured: immediately after surgery
implant stability
using radiofrequency analysis
Measured: one month
implant stability
using radiofrequency analysis
Measured: three months
implant stability
using radiofrequency analysis
Measured: six months
bone density
bone density around the implant is measured in cone beam computed tomography
Measured: three months
Secondary outcomes (2)
propping depth
The distance between the gingival margin and the base of the pocket
Measured: six months
bleeding inex
Modified sulcus bleeding index
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Twenty implants were inserted in patients seeking for replacement of missed single or multiple posterior maxillary teeth. Patients were divided randomly into two groups. In the control group, ten implants were placed and immediately loaded. While in the study group, ten implants were coated with hyaluronic acid (HA) immediately before placement and immediately loaded. All patients were clinically evaluated at implant placement time, one, three and six months after loading regarding implant stability. Peri-implant pocket depth and modified sulcus bleeding index were evaluated clinically at six months in all patients. Bone density was evaluated radiographically after three months. All clinical and radiographic data were subjected to statistical analysis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403099
- Sponsor's protocol ID
- 01010119
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
- ClinicalTrials.gov ID
- NCT05403099
- Acronym / sponsor ID
- 01010119
- Conditions
- Missing Teeth
- Keywords
- Hyaluronic Acid, dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 3 Jun 2022 (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.
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Detailed description
Patients were randomly divided into two groups:
Group I (Control group):
Ten implants were placed in posterior maxilla and immediately loaded.
Group II (Study group):
Ten implants were coated with HA before placement in posterior maxilla and immediately loaded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Twenty implants were inserted in patients seeking for replacement of missed single or multiple posterior maxillary teeth. Patients were divided randomly into two groups. In the control group, ten implants were placed and immediately loaded. While in the study group, ten implants were coated with hyaluronic acid (HA) immediately before placement and immediately loaded. All patients were clinically evaluated at implant placement time, one, three and six months after loading regarding implant stability. Peri-implant pocket depth and modified sulcus bleeding index were evaluated clinically at six months in all patients. Bone density was evaluated radiographically after three months. All clinical and radiographic data were subjected to statistical analysis.
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: conventional implant placementEach implant was placed into the prepared implant site. |
| Hyaluronic acid | Experimental | Other: Hyaluronic acidEach implant was placed after topical application of HA on its surface |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Highly motivated patients with good oral hygiene.
- Age 18 years or older.
- Adequate alveolar bone volume at the implant site, at least 6mm in width and 15 mm in height.
- Free from any parafunctional habits
Key exclusion criteria (3 listed)
- Patients suffering from any systemic or local disease that contraindicate implant placement or surgery.
- Pregnancy.
- Smokers.
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 acidimmediate placement of dental implant after topical application of hyaluronic acid on implant surface | Other | Hyaluronic acid |
| conventional implant placementimmediate placement of dental implant without application of hyaluronic acid on implant surface | Other | control |
Primary outcome
implant stability
Time frame: immediately after surgery
using radiofrequency analysis
implant stability
Time frame: one month
using radiofrequency analysis
implant stability
Time frame: three months
using radiofrequency analysis
implant stability
Time frame: six months
using radiofrequency analysis
bone density
Time frame: three months
bone density around the implant is measured in cone beam computed tomography
2 secondary outcomes
propping depth
Time frame: six months
bleeding inex
Time frame: six months
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 3 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Missing Teeth
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Active, not recruiting
Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Tooth Loss, Edentulism
Not yet recruitingPhase 4
S-TiUltra Implant Study
Missing Tooth/Teeth
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
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 Hyaluronic acid and conventional implant placement in people with Missing Teeth, run by Mansoura 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 4 inclusion and 3 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 3 Jun 2022. 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?
implant stability (time frame: immediately after surgery). The study lists 5 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 3 Jun 2022.