A Modern, Non-surgical Method for Treating Papillary Deficiencies is the Use of Hyaluronic Acid, Which Have Demonstrated Encouraging Outcome. Subperiosteal Hyaluronic Acid Injection Overlay Technique with the Idea of Merging Hyaluronic Acid Injection with Surgical Intervention to Reconstruct Idp

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

The interdental papilla is a crucial part of an esthetic smile, its loss results in gingival black triangles giving unpleasant appearance which directly affect patient self-esteem (Lee et al. 2016). The presence of interdental papilla is of great concern for the clinician and the patient. Gingival black triangles are considered to be the most disliked esthetic issue. As well open embrasures can cause food impaction and phonetic problems (Prato et al. 2004).

The treatment of black triangles is challenging in modern dentistry. The treatment options are surgical and non-surgical. Surgical treatments are invasive and do not always give a predictable result due to limited blood supply of the papilla (Mansouri 2013).

However, no technique has been set up as a gold standard treatment for gingival black triangles, although, connective tissue graft surgical techniques are the most common used approaches for treatment of black triangles (RahimiRad 2018).

A modern, non-surgical method for treating papillary deficiencies is the use of hyaluronic acid, which have demonstrated encouraging outcome (Ni et al. 2021). Subperiosteal hyaluronic acid injection overlay technique was proposed by Spano et al, (2020) with the idea of merging hyaluronic acid injection with simple surgical intervention to reconstruct the lost interdental papilla. As far as we know, there is no present studies comparing hyaluronic acid overlay technique with connective tissue graft in treatment of interdental papilla deficiencies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Subperiosteal hyaluronic acid injection overlay technique

    Procedure/Surgery

    using subperiosteal hyaluronic acid injection overlay technique showed promising results in treating lost interdental papilla which needs further assessment to its clinical effectiveness

  • Tunneling with connective tissue graft.

    Procedure/Surgery

    Connective tissue graft base techniques have been for years the most predictable approach for treatment of interdental papillary defects. CTG can as a biological filler which enhances flap stability and wound strength. CTG also can promote coagulation cascade and protects the maturating fibrin clot (Tavelli et al. 2019). Moreover, CTG results in significant increase in gingival tissue thickness which positively improve tissue fill and soft tissue volume creeping which influence esthetic outcomes following periodontal regeneration

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in papilla height

Clinical changes in papilla will be recorded by measuring papilla height at the distance between the tip of the papilla and the incisal edge of the adjacent tooth using UNC periodontal probe .

Time frame
Changes will be recorded at 3, 6 and 12 months

Secondary outcomes

1

Percentage of changes in papilla height

the percentage of change in papilla height will be calculated with a reference to baseline following equation PH baseline- PH timepoint / PH baseline

Time frame
3, 6 and 12 months
2

Papilla presence index

The papilla presence index will be recorded at baseline, 3, 6 and 12 months follow up. The scores will be measured as follows: PPI 1: When the papilla is completely present and coronally extends to the contact point to completely fill the embrasure. It is at same level of adjacent papilla PPI 2: Papilla is no longer completely present and lies apical to the contact point and not at the same level as the adjacent papillae, but the interproximal CEJ is still not visible. PPI 3: Papilla is moved more apical and the interproximal CEJ becomes visible. PPI 4: Papilla lies apical to both the interproximal CEJ and buccal CEJ.

Time frame
3, 6 and 12 months
3

Clinical attachment loss

A UNC probe will used to estimate this measurement. The probe will be inserted in the gingival sulcus and CAL will be measured as the distance from CEJ to the bottom of the sulcus

Time frame
3, 6 and 12 months
4

Gingival thickness

Gingival thickness will be measured 2 mm apical to the gingival margin with an aesthetic needle with a silicon stopper. The needle will be inserted perpendicular to the mucosal surface, through soft tissue with light pressure until resistance will be felt once the tip of needle is in contact with bone. The silicone stopper will be moved towards until it reaches the external surface of mucosal tissues. The penetration depth will be measured using UNC graduated probe by measuring the distance from the tip of the needle to silicone stopper

Time frame
3, 6 and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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