Immediate Dental ImplantPhase 4NCT03804177
The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant in Anterior Region
A Phase 4 study testing immediate implant placement with melatonin hyaluronic acid vit C and immediate implant placement without melatonin hyaluronic acid vit C in people with Immediate Dental Implant, run by Cairo University.
Trial summary
The concept of immediate implant placement at the time of tooth extraction was first introduced by Schulte et al. on animal studies. Since then, many follow-up studies examining different variables have supported the concept of immediate implant placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant
- What is being tested?
- immediate implant placement with melatonin hyaluronic acid vit C and immediate implant placement without melatonin hyaluronic acid vit C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2019to 30 Apr 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-60.
- Systemically healthy patients indicated for single or multiple immediate implants in anterior and premolar region.
- Absence of any peri-apical pathosis.
- Patients with intact buccal plate of bone.
- Patients with adequate bone volume for the dental implant procedure.
- Patient consent approval and signing.
Who cannot join
- 1. Smokers. 2. Systemic disease that may affect the final outcome of the surgical procedure.
- 3. No or poor patient's compliance. 4. Patients with psychological problems. 5. Pathology at the site of intervention. 6. Pregnant patients. 7. Patients refuse to sign an informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant Placement in Anterior and Premolar Region in Systemically Healthy Patients
The concept of immediate implant placement at the time of tooth extraction was first introduced by Schulte et al. on animal studies. Since then, many follow-up studies examining different variables have supported the concept of immediate implant placement. pioneered a major contribution to immediate implant placement in human studies which recommended the insertion of an implant into a fresh extraction socket.
They advocated immediate implant placement primarily to reduce the number of surgical interventions needed to perform an implant-supported rehabilitation and shorten the treatment time.
Read more
Placement of implants immediately into extraction sites allow the surgeon to idealize the position of the implant appropriately with a better rehabilitation of the normal contour to the facial aspect of the final restoration.
Immediate implant placement in fresh extraction sockets was reported to reduce alveolar bone resorption. Better esthetic outcomes were achieved including the prosthetic crown length in harmony with the adjacent teeth, natural scalloping and easier distinct papillae to achieve and maximum soft tissue support.
Hyaluronic acid is a glycosaminoglycan, this unique molecule is implicated In a variety of biological functions including structural integrity, and the regulation of embryologic development. It is described as a natural organic substance, with physiological therapy activity, main component of the extracellular matrix of many tissues such as the skin, synovial joints and periodontal tissues .
- Conditions
- Immediate Dental Implant
- Being tested
- immediate implant placement with melatonin hyaluronic acid vit C, immediate implant placement without melatonin hyaluronic acid vit C
- Keywords
- immediate implant, hyaluronic acid, melatonin, vitamin C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement with melatonin hyaluronic acid vit CProcedure or surgery
Also called early implant placement
immediate implant placement with melatonin and hyaluronic acid and systemic administration vitamin C
immediate implant placement without melatonin hyaluronic acid vit CProcedure or surgery
Also called early implant placement
immediate implant placement without melatonin and hyaluronic acid and systemic administration vitamin C
| Study group | Role | What they receive |
|---|---|---|
| implant with hyaluronic melatonin vit c | Experimental | implant placement with topical application of hyaluronic and melatonin and systemic administration of vitamin C Receives: Procedure: immediate implant placement with melatonin hyaluronic acid vit C |
| immediate implant | Active comparator | immediate implant placement alone without melatonin or hyauronic acid nor vitamin c Receives: Procedure: immediate implant placement without melatonin hyaluronic acid vit C |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
implant stability by ostell
Measured: 6 months
Secondary outcomes (1)
soft tissue healing
soft tissue healing by likert scale (0 indicate complete soft tissue Closure (no line of fibrin) , 1 indicate complete closure (thin line of fibrin) , 2 indcate complete closure (fibrin) , 3 indicate in complete closure (dehiscence ) , 4 indicate incomplete closure (necrosis)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start10 Feb 2019 (estimated)
- Primary completion10 Feb 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immediate Dental ImplantStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- it is randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Nabil Abdelfatiah, Cairo University
- Investigators
- Mona darhous, PHD, Study chair, Cairo UniversityMona shoieb, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804177
- Sponsor's protocol ID
- perio25111987
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i will check with my study chair
Publications
Lee JH, Kim J, Baek HR, Lee KM, Seo JH, Lee HK, Lee AY, Zheng GB, Chang BS, Lee CK. Fabrication of an rhBMP-2 loaded porous beta-TCP microsphere-hyaluronic acid-based powder gel composite and evaluation of implant osseointegration. J Mater Sci Mater Med. 2014 Sep;25(9):2141-51. doi: 10.1007/s10856-014-5250-0. Epub 2014 Jun 14.
PubMed 24928668El-Gammal MY, Salem AS, Anees MM, Tawfik MA. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial. J Oral Implantol. 2016 Apr;42(2):119-25. doi: 10.1563/aaid-joi-D-14-00277. Epub 2015 Jun 23.
PubMed 26103559
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Hyaluronic Acid And Melatonin With Systemic Administration of Vitamin C On Implant Stability After Immediate Implant Placement in Anterior and Premolar Region in Systemically Healthy Patients
- ClinicalTrials.gov ID
- NCT03804177
- Acronym / sponsor ID
- perio25111987
- Conditions
- Immediate Dental Implant
- Keywords
- immediate implant, hyaluronic acid, melatonin, vitamin C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2019 (estimated)
- Primary completion
- 10 Feb 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 15 Jan 2019 (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 concept of immediate implant placement at the time of tooth extraction was first introduced by Schulte et al. on animal studies. Since then, many follow-up studies examining different variables have supported the concept of immediate implant placement. pioneered a major contribution to immediate implant placement in human studies which recommended the insertion of an implant into a fresh extraction socket.
They advocated immediate implant placement primarily to reduce the number of surgical interventions needed to perform an implant-supported rehabilitation and shorten the treatment time.
Placement of implants immediately into extraction sites allow the surgeon to idealize the position of the implant appropriately with a better rehabilitation of the normal contour to the facial aspect of the final restoration.
Immediate implant placement in fresh extraction sockets was reported to reduce alveolar bone resorption. Better esthetic outcomes were achieved including the prosthetic crown length in harmony with the adjacent teeth, natural scalloping and easier distinct papillae to achieve and maximum soft tissue support.
Hyaluronic acid is a glycosaminoglycan, this unique molecule is implicated In a variety of biological functions including structural integrity, and the regulation of embryologic development. It is described as a natural organic substance, with physiological therapy activity, main component of the extracellular matrix of many tissues such as the skin, synovial joints and periodontal tissues .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- it is randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| implant with hyaluronic melatonin vit c | Experimental | Procedure: immediate implant placement with melatonin hyaluronic acid vit Cimplant placement with topical application of hyaluronic and melatonin and systemic administration of vitamin C |
| immediate implant | Active comparator | Procedure: immediate implant placement without melatonin hyaluronic acid vit Cimmediate implant placement alone without melatonin or hyauronic acid nor vitamin c |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-60.
- Systemically healthy patients indicated for single or multiple immediate implants in anterior and premolar region.
- Absence of any peri-apical pathosis.
- Patients with intact buccal plate of bone.
- Patients with adequate bone volume for the dental implant procedure.
Key exclusion criteria (2 listed)
- 1. Smokers. 2. Systemic disease that may affect the final outcome of the surgical procedure.
- 3. No or poor patient's compliance. 4. Patients with psychological problems. 5. Pathology at the site of intervention. 6. Pregnant patients. 7. Patients refuse to sign an informed consent.
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 |
|---|---|---|
| immediate implant placement with melatonin hyaluronic acid vit CAlso: early implant placementimmediate implant placement with melatonin and hyaluronic acid and systemic administration vitamin C | Procedure or surgery | implant with hyaluronic melatonin vit c |
| immediate implant placement without melatonin hyaluronic acid vit CAlso: early implant placementimmediate implant placement without melatonin and hyaluronic acid and systemic administration vitamin C | Procedure or surgery | immediate implant |
Primary outcome
implant stability
Time frame: 6 months
implant stability by ostell
1 secondary outcome
soft tissue healing
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Background: PubMed 24928668Lee JH, Kim J, Baek HR, Lee KM, Seo JH, Lee HK, Lee AY, Zheng GB, Chang BS, Lee CK. Fabrication of an rhBMP-2 loaded porous beta-TCP microsphere-hyaluronic acid-based powder gel composite and evaluation of implant osseointegration. J Mater Sci Mater Med. 2014 Sep;25(9):2141-51. doi: 10.1007/s10856-014-5250-0. Epub 2014 Jun 14.
- Background: PubMed 26103559El-Gammal MY, Salem AS, Anees MM, Tawfik MA. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial. J Oral Implantol. 2016 Apr;42(2):119-25. doi: 10.1563/aaid-joi-D-14-00277. Epub 2015 Jun 23.
- Individual participant dataSharing planned: Undecided. i will check with my study chair
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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.
Mona darhous, PHD study chair
Cairo University
Mona shoieb, PHD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing immediate implant placement with melatonin hyaluronic acid vit C and immediate implant placement without melatonin hyaluronic acid vit C in people with Immediate Dental Implant, run by Cairo University.
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 6 inclusion and 2 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact ahmed Nasser, Msc (00201094959526, ahmedelsawi8787@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant stability (time frame: 6 months). 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 NCT03804177, which also lists 2 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 16 Jan 2019.