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Pontic Site AugmentationNCT06926452

Clinical and Volumetric Changes Following Single Pontic Site Development Using Multilayered Platelet Rich Fibrin Versus Connective Tissue Grafting in the Maxillary Esthetic Zone

A study testing Pontic site augmentation with sub-epithelial connective tissue graft. and Pontic site augmenation using multi-layered platelet rich fibrin in people with Pontic Site Augmentation and Connective Tissue Graft, run by Cairo University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In clinical practice most patients' first concern is esthetics, soft tissue grafting is becoming routine in clinical practice to make up for the deficiency in supra-crestal tissue dimension that typically follows tooth loss. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Pontic site augmentation with sub-epithelial connective tissue graft. and Pontic site augmenation using multi-layered platelet rich fibrin
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
May 2025to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults from the age of 18 - 40 years
  • Patients with missing maxillary teeth/tooth in the area from 2nd premolar to 2nd premolar with ridge defect according to Seibert classification (Class I, II and III).
  • Intact gingival tissue with at least 2mm keratinized tissue.
  • Periodontally healthy patients.
  • Patients accepts to provide informed consent.

Who cannot join

  • Smokers.
  • Pregnant females.
  • Handicapped and mentally challenged patients.
  • Systemic disease compromising wound healing.
  • Active soft tissue infection

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Joseph Osama Kostandy, Bachelor Degree of dentsitry contact

+2001226718007 ext. 022

joseph.osama@dentistry.cu.edu.eg

About this study

In clinical practice most patients' first concern is esthetics, soft tissue grafting is becoming routine in clinical practice to make up for the deficiency in supra-crestal tissue dimension that typically follows tooth loss. The edentulous site experiences major qualitative and quantitative changes because of a number of sequential events that occur after tooth extraction. Ridge dimensional alterations of the underlying bone and the soft tissue architecture overlaying it are the consequence of the socket healing process. To maintain the remaining teeth, aesthetic jaw support and optimal food chewing, lost teeth must be replaced. The teeth adjacent to and opposing a missing tooth will eventually tip, shift, and migrate, disrupting normal function. One integral part of the new strategy for treating periodontal diseases is thought to be surgical periodontal operations. Soft tissue grafting has become more frequently utilized to improve the aesthetics of teeth and dental implant sites by treating mucogingival abnormalities, restoring an appropriate width of keratinized tissue, and enhancing tissue thickness. SCTG has its own limitations, such as lack of graft availability, need for a second surgical site, proximity to palatine neurovascular complex and unaesthetic tissue contour at the recipient site. Due to these limitations, investigations on more regenerative nature techniques have been explored such as PRF, Using PRF instead of SCTG has the added value of decreasing discomfort and postoperative pain after the surgical procedure due to having additional donor site, To the best of our knowledge testing multi-layer PRF against SCTG in pontic site augmentation was never done before.

Read the detailed description

In clinical practice most patients' first concern is esthetics, soft tissue grafting is becoming routine in clinical practice to make up for the deficiency in supra-crestal tissue dimension that typically follows tooth loss. The edentulous site experiences major qualitative and quantitative changes because of a number of sequential events that occur after tooth extraction. Ridge dimensional alterations of the underlying bone and the soft tissue architecture overlaying it are the consequence of the socket healing process. To maintain the remaining teeth, aesthetic jaw support and optimal food chewing, lost teeth must be replaced. The teeth adjacent to and opposing a missing tooth will eventually tip, shift, and migrate, disrupting normal function. One integral part of the new strategy for treating periodontal diseases is thought to be surgical periodontal operations. Soft tissue grafting has become more frequently utilized to improve the aesthetics of teeth and dental implant sites by treating mucogingival abnormalities, restoring an appropriate width of keratinized tissue, and enhancing tissue thickness. SCTG has its own limitations, such as lack of graft availability, need for a second surgical site, proximity to palatine neurovascular complex and unaesthetic tissue contour at the recipient site. Due to these limitations, investigations on more regenerative nature techniques have been explored such as PRF, Using PRF instead of SCTG has the added value of decreasing discomfort and postoperative pain after the surgical procedure due to having additional donor site, To the best of our knowledge testing multi-layer PRF against SCTG in pontic site augmentation was never done before.

Following tooth extraction, alveolar bone loss and structural and compositional changes of the covering soft tissues, as well as morphological alterations, can be expected. The numerous alterations in the alveolar process may lead to difficulties at the time of implant placement when a prosthetically driven implant position is desired, SCTG has its own limitations, such as lack of graft availability, need for a second surgical site, proximity to palatine neurovascular complex and unaesthetic tissue contour at the recipient site. The use of the SCTG in periodontal surgery is considered the golden pattern to the gingival recession treatment due to its characteristics of quick keratinization and adherence. However, the application of the technique is limited by the thickness of the giver tissue, anatomical factors, technical difficulty, and the need of an additional giver site. Due to these limitations, investigations on more regenerative nature techniques have been explored such as PRF. Platelet-Rich Fibrin (PRF) is an autologous biomaterial obtained from a patient's blood, rich in platelets, growth factors, and fibrin, which has regenerative and healing properties. Multi-layer PRF (ML-PRF) involves stacking several PRF membranes to increase their volumetric effect and improve tissue healing in areas requiring soft tissue augmentation.

Being tested
Pontic site augmentation with sub-epithelial connective tissue graft., Pontic site augmenation using multi-layered platelet rich fibrin
Keywords
Pontic site augmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pontic site augmentation with sub-epithelial connective tissue graft.Procedure or surgery

    Pontic site augmentation with sub-epithelial connective tissue graft.

  • Pontic site augmenation using multi-layered platelet rich fibrinProcedure or surgery

    Pontic site augmenation using multi-layered platelet rich fibrin

Study groups in NCT06926452
Study groupRoleWhat they receive
ControlActive comparatorNot described
Receives: Procedure: Pontic site augmentation with sub-epithelial connective tissue graft.
TestExperimentalNot described
Receives: Procedure: Pontic site augmenation using multi-layered platelet rich fibrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Keratinized tissue thickness

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
Randomized controlled clinical trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06926452
Sponsor's protocol ID
PRF vs CTG
Status last verified
Apr 2025
First submitted
7 Apr 2025
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Pontic site augmentation with sub-epithelial connective tissue graft. and Pontic site augmenation using multi-layered platelet rich fibrin in people with Pontic Site Augmentation and Connective Tissue Graft, 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Apr 2025. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joseph Osama Kostandy, Bachelor Degree of dentsitry (+2001226718007 ext. 022, joseph.osama@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Keratinized tissue thickness (time frame: 6 months). 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 13 Apr 2025.

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