Deficient Interdental PapillaPhase 3NCT07597135
Comparative Evaluation of Alb PRF Versus Connective Tissue Graft in Reconstruction of Deficient Interdental Papilla
A Phase 3 study testing Albumin (5% serum-protein solution containing immunoglobulins) and connective tissue graft in people with Deficient Interdental Papilla, run by ahmed mostafa ahmed abo el soud.
Trial summary
This study will evaluate the efficacy of Alb PRF membrane in comparison to a subepithelial connective tissue graft in the reconstruction of interdental papillae. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deficient Interdental Papilla
- What is being tested?
- Albumin (5% serum-protein solution containing immunoglobulins) and connective tissue graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2026to 20 Dec 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- inter dental papilla deficincy
Who cannot join
- smokers
About this study
Official title: Evaluation of Albumin Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft in Interdental Papilla Reconstruction: a Randomized Controlled Clinical Trial
This study will evaluate the efficacy of Alb PRF membrane in comparison to a subepithelial connective tissue graft in the reconstruction of interdental papillae.
Read the detailed description
the reconstruction will be done using the Hans Taki surgical technique, while Alb PRF will be used as a membrane.
- Conditions
- Deficient Interdental Papilla
- Being tested
- Albumin (5% serum-protein solution containing immunoglobulins), connective tissue graft
- Keywords
- interdental papilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin (5% serum-protein solution containing immunoglobulins)Biological
a variation of PRF done by heating up to 75 degree then mixed with the remaining prf to get membrane
connective tissue graftBiological
subepithelial connective tissue graft
| Study group | Role | What they receive |
|---|---|---|
| connective tissue graft | Active comparator | Not described Receives: Biological: connective tissue graft |
| Albumin plasma rich fibrin membrane | Experimental | Not described Receives: Biological: Albumin (5% serum-protein solution containing immunoglobulins) |
What is being measured
The primary outcome is the main question the study is designed to answer.
papillary height measured from apical part of contact point to tip of papilla (CP-TP)
Measured: from enrollment, 3 months, 6months, 9months, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start20 Jun 2026 (estimated)
- Primary completion20 Sep 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficient Interdental PapillaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ahmed mostafa ahmed abo el soud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ahmed mostafa ahmed abo el soud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597135
- Sponsor's protocol ID
- Alb-PRF vs connective tissue
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Albumin Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft in Interdental Papilla Reconstruction: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07597135
- Acronym / sponsor ID
- Alb-PRF vs connective tissue
- Conditions
- Deficient Interdental Papilla
- Keywords
- interdental papilla
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- ahmed mostafa ahmed abo el soudUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 20 Sep 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 19 May 2026 (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.
This study will evaluate the efficacy of Alb PRF membrane in comparison to a subepithelial connective tissue graft in the reconstruction of interdental papillae.
Detailed description
the reconstruction will be done using the Hans Taki surgical technique, while Alb PRF will be used as a membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| connective tissue graft | Active comparator | Biological: connective tissue graft |
| Albumin plasma rich fibrin membrane | Experimental | Biological: Albumin (5% serum-protein solution containing immunoglobulins) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- inter dental papilla deficincy
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Albumin (5% serum-protein solution containing immunoglobulins)a variation of PRF done by heating up to 75 degree then mixed with the remaining prf to get membrane | Biological | Albumin plasma rich fibrin membrane |
| connective tissue graftsubepithelial connective tissue graft | Biological | connective tissue graft |
Primary outcome
papillary height measured from apical part of contact point to tip of papilla (CP-TP)
Time frame: from enrollment, 3 months, 6months, 9months, 12months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
Related trials for Deficient Interdental Papilla
Not yet recruiting
Microneedling-Assisted Hyaluronic Acid for Interdental Papilla Deficiency
Interdental Papilla Deficiency
Not yet recruiting
Microneedling-Assisted i-PRF for Interdental Papilla Deficiency
Interdental Papilla Deficiency
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albumin (5% serum-protein solution containing immunoglobulins) and connective tissue graft in people with Deficient Interdental Papilla, run by ahmed mostafa ahmed abo el soud.
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 1 inclusion and 1 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 19 May 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
papillary height measured from apical part of contact point to tip of papilla (CP-TP) (time frame: from enrollment, 3 months, 6months, 9months, 12months). 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 19 May 2026.