ClinicalTrials.gg
Status unknownNCT03804177Updated Jan 16, 2019

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 interventional study of immediate implant placement with melatonin hyaluronic acid vit C and immediate implant placement without melatonin hyaluronic acid vit C in Immediate Dental Implant, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-16.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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 .

02

Conditions studied

  • Immediate Dental Implant

Keywords

  • immediate implant
  • hyaluronic acid
  • melatonin
  • vitamin C
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: 18-60.
  2. Systemically healthy patients indicated for single or multiple immediate implants in anterior and premolar region.
  3. Absence of any peri-apical pathosis.
  4. Patients with intact buccal plate of bone.
  5. Patients with adequate bone volume for the dental implant procedure.
  6. Patient consent approval and signing.

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    implant with hyaluronic melatonin vit c

    implant placement with topical application of hyaluronic and melatonin and systemic administration of vitamin C

    Procedure: immediate implant placement with melatonin hyaluronic acid vit C

  • Active comparator
    immediate implant

    immediate implant placement alone without melatonin or hyauronic acid nor vitamin c

    Procedure: immediate implant placement without melatonin hyaluronic acid vit C

Interventions

  • Procedureimmediate implant placement with melatonin hyaluronic acid vit C

    immediate implant placement with melatonin and hyaluronic acid and systemic administration vitamin C

    Also known as: early implant placement

  • Procedureimmediate implant placement without melatonin hyaluronic acid vit C

    immediate implant placement without melatonin and hyaluronic acid and systemic administration vitamin C

    Also known as: early implant placement

06

What researchers measure

Primary outcomes

  1. implant stability

    implant stability by ostell

    Time frame: 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)

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 24928668 ↗
  • El-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 ↗

Individual participant data

Plan to share: Undecided — i will check with my study chair

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2019; primary completion for Feb 2022, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2019
First posted
Jan 15, 2019
StartEst.
Feb 10, 2019
Primary completionEst.
Feb 10, 2022
CompletionEst.
Apr 30, 2022
Last update
Jan 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03804177
Lead sponsor
Cairo University
Responsible party
Ahmed Nabil Abdelfatiah (assistant lecturer, Cairo University) — Principal investigator
First posted
Jan 15, 2019
Start date
Feb 10, 2019 (estimated)
Primary completion
Feb 10, 2022 (estimated)
Completion
Apr 30, 2022 (estimated)
Last update
Jan 16, 2019

Study contacts

ahmed Nasser, Msc
Contact
ahmedelsawi8787@gmail.com
00201094959526
Mona darhous, PHD
study chair · Cairo University
Mona shoieb, PHD
study chair · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion