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Papillary ReconstructionNCT07159802

Papillary Reconstruction Using Three Different Modalities

A study testing Papillary reconstruction in people with Papillary Reconstruction, run by Mansoura University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

papillary reconstruction will be done by three techniques : injection of hyaluronic acid in the base of the papilla and booster doses can be required , injection of ALB-PRF which resorbs slowly and so longer effect the last technique is minimal invasive surgery which is a modification of beagle's technique Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Papillary Reconstruction
What is being tested?
Papillary reconstruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteEgypt
Study dates
25 Feb 2025to 30 Apr 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 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1. Age: 20 to 50 years. 2. Class 1 and 2 inter dental papilla loss according to Nordland \& Tarnow classification (17).
  • 3. Adequate attached gingiva (minimum 3 mm). 4. Stage 1or 2 periodontitis (18).

Who cannot join

  • 1. Smokers. 2. Chronic systemic diseases. 3. Drug usage. 4. High frenum attachment. 5. Diastema. 6. Pregnancy and lactation. 7. Stage 3 \& 4 periodontitis (18). 8. Noncompliance with oral hygiene measures.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Mansoura University

    Al Mansurah, Dakahlia Governorate, 35516

    Tasneem E Abdallah, BDS, 01097217205 ext. 002, tasneemehabgamal@mans.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Restoring Lost Pink Triangle by Comparing Three Different Papillary Reconstruction Modalities: A Randomized Clinical Trial

papillary reconstruction will be done by three techniques : injection of hyaluronic acid in the base of the papilla and booster doses can be required , injection of ALB-PRF which resorbs slowly and so longer effect the last technique is minimal invasive surgery which is a modification of beagle's technique

Read the detailed description

Interdental papilla (IDP) is the component of gingiva which occupies the cervical embrasure between proximal surfaces of the teeth. It is triangular when observed two dimensionally and pyramidal when viewed three dimensionally. Its shape, position, and presence are dependent upon the presence of underlying alveolar bone proper, proximal contact points, and area of adjacent teeth (1). This entity is also known as the interdental papillary house by Gonzalez et al (2), where the dimensions of the roof, floor and lateral walls of the interdental house help in maintaining the interdental papilla.

The function of the IDP is not only deflection of food debris but also acts as a barrier to protect the underlying periodontal tissues. A 'round cell infiltration' is found in the interdental papillae. The inflammatory infiltrate demonstrates a defense mechanism to the constant threat of bacterial invasion from dental plaque accumulation. The presence of the IDP also plays an essential role in aesthetics (3). The gingival unit is one of the key factors in maintaining esthetics and for this reason the presence of a normal sized and harmonically shaped IDP becomes crucial (4). It creates visual harmony between the gingiva topography and surrounding gingiva contours (5). Its deficiency can lead to a negative impact in the oral health-related quality of life and self-esteem for the patient.

If there is any defect of alveolar bone proper or adjacent tooth contact, the IPD will fail to sustain its original form resulting in empty space between teeth. This space is commonly referred as a black triangle or open gingival embrasure as a result of deficiency or loss of papilla beneath the contact points. This black triangle has many negative consequences as unpleasant appearance while smiling, food impaction and phonetic problems (6). Numerous risk factors lead to the development of this problem (7). These factors include aging, periodontal disease, loss of height of the alveolar bone relative to the interproximal contact, length of embrasure area, root angulations, tooth loss, faulty oral hygiene procedures, interproximal contact position, and triangular-shaped crowns (8, 9).

Due to its aesthetic impact and mandatory role, dentists always in a continuous challenge to restore the lost pink triangle because this region is characteristically narrow making surgery more difficult and limiting the blood supply to the associated soft tissue (5,10). Treatment options for papillary reconstruction could be surgical, non-surgical or ortho-restorative in nature which vary in long term success rates.

Currently the standard procedures for papillary reconstruction (PR) are sulcular releasing incisions, coronal flap movement and connective tissue graft (CTG) being replaced interproximally. Connective tissue graft with a coronally advanced flap is preferred more frequently than others. Despite its advantages, the presence of a second wound site and variable PR outcomes still leads the clinicians to search for alternatives (10).

Recently all the studies are directed toward less invasive techniques to minimize post operative discomfort, decrease number of surgical sites \& improve patient satisfaction. These techniques include non-surgical injection of hyaluronic acid or platelet rich fibrin (PRF) and minor surgeries such as placement of PRF on semilunar incision or pedicle grafts as it will be described later.

Hyaluronan (HA) is a component in extracellular matrix that regulates the cells behavior, tissue environment and tissue regeneration. It has been extensively used in aesthetic products. Recently, HA has been introduced as a less invasive procedure to treat black triangle (11). The currently available injectable hyaluronic acid gels are polymers that are formulated by crosslinking hyaluronic acid produced by Streptococcus species. Injection is done on multiple sessions to ensure complete papilla regeneration (5).

Platelet rich fibrin is recommended as a supportive or alternative to CTG in periodontal surgery to benefit from its dense fibrin structure and growth factors content, that enhance wound healing and tissue formation (10). It plays a vital role in differentiation of precursor cells for regeneration of interdental papilla (12). Notably, involvement of PRF in neo angiogenesis could potentially reduce necrosis and shrinkage of the surgical flap (13, 14).

Injectable albumin platelet rich fibrin (Alb-PRF) is a recent form of PRF which overcomes limitations of previous forms such as rapid absorption. This modified biocompatible biologic product has a long degradation period that accelerates papilla regeneration by the continuous release of growth factors and increases the absorption time from two weeks to more than four months. Albumin gel is formed by heating the platelet-poor plasma (PPP) and mixed with liquid PRF to form Alb-PRF gel (15).

Modified Beagle's technique is another novel minimally invasive surgical approach for restoring lost IDP. The standard Beagle's technique includes partial thickness incision along the line angles of adjacent teeth on the palatal aspect then it's elevated and folded on the labial aspect. So our technique is a variant of Beagle's technique to achieve soft tissue augmentation of anterior interproximal space, without requiring a second surgical site. It consists of a small pedicle flap elevated from labial side and folded upon itself. Furthermore, this procedure is less time-consuming and surgically more simple (7).

For all methods to be successful, surgical procedures must maintain the integrity of interproximal tissues (16). Currently there are no randomized clinical trials comparing these minimal invasive methods and that's what we will explore in this study.

Being tested
Papillary reconstruction
Keywords
Papillary reconstruction, Hyalouronic acid, PRF

What participants receive

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

  • Papillary reconstructionProcedure or surgery

    This study will be conducted to compare the effectiveness of three papillary reconstruction techniques: modified Beagle's technique, injection of albumin PRF, and injection of Hyaluronic Acid filler.

    Primary outcome: volumetric assessment of papilla regeneration. Secondary outcome: improvement of pink esthetic score.

Study groups in NCT07159802
Study groupRoleWhat they receive
Hyaluronic acid groupExperimental* The needle of the injectable HA is inserted at a 45 angle in an area 3 to 4 mm apical to the interdental papilla tip. * A one-point injection technique is performed on the connective tissue of the interdental papilla, ensuring the bevel is up by pointing the slant of the needle upward. * The amount of injection for every session is about 0.2 ml. * Then, the interdental papilla tip is lightly molded in the direction of the incisal edge with gauze for 1 min. * This procedure can be repeated up to five times during 3-week intervals until no black triangle is clinically observable (5).
Receives: Procedure: Papillary reconstruction
Alb PRF groupExperimental* A total of 9 mL of whole blood from each patient will be collected in a plastic tube. * It will be centrifuged at 700 g for 8 minutes at room temperature. * After centrifugation, the upper 2 mL of PPP will be collected in a syringe and heated for 10 minutes at 75°C to prepare denatured albumin (albumin gel). * Then, the tube will be given another 10 minutes to cool to room temperature. * The residual cells and growth factors in the buffy coat (liquid PRF) will be mixed with the cooled albumin gel and Alb-PRF gel will be ready for injection via a sterile syringe-to-syringe connector. * Alb-PRF gel will be injected into the papilla at a distance of 3-4 mm apical to the tip of the papilla and at an angle of 45º to the longitudinal axis of the adjacent teeth. * Patients will be recalled three weeks after injection to receive a booster dose (15).
Receives: Procedure: Papillary reconstruction
Modified Beagle's technique group:Experimental* Two parallel vertical incisions are placed in the interdental gingiva starting from the coronal end of the papilla near the proximal contact points and extended apically longer than the length of the black triangle. * These two incisions are joined by a horizontal incision to create a pouch. * A partial thickness flap is raised from the apical end and gently advanced coronally towards the contact point. * The partial thickness is then rolled and folded on itself and sutured using 3-0 silk suture to keep it in the designated position. * During suturing, the suture is circumferentially wound around adjacent teeth to avoid any displacement. * Periodontal dressing will be given to provide mechanical protection(19).
Receives: Procedure: Papillary reconstruction

What is being measured

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

  1. volumetric assessment of papilla regeneration.

    By intraoral scanner \& image analysis

    Measured: 6 months

Secondary outcomes (1)
  1. improvement of pink esthetic score.

    Using pink esthetic score scale

    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 posted8 Sep 2025
  2. Study start25 Feb 2025
  3. Primary completion25 Apr 2026 (estimated)
  4. Study completion30 Apr 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
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07159802
Sponsor's protocol ID
A02010250M
Status last verified
Jan 2025
First submitted
29 Aug 2025
Last updated
8 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Papillary reconstruction in people with Papillary Reconstruction, 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 2 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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?

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 Tasneem E Abdallah, BDS (01097217205 ext. 002, tasneemehabgamal@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

volumetric assessment of papilla regeneration. (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 8 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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