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Reconstruction of Interdental Papilla Using Hyaluronic Acid

The Role of Hyaluronic Acid in Reconstruction of Interdental Papilla in The Esthetic Zone

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02119741
Enrollment
30
Registered
2014-04-22
Start date
2014-05-31
Completion date
2015-10-31
Last updated
2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defected Interdental Papilla

Keywords

Interdental papilla, hyaluronic acid, esthetic zone, black triangles

Brief summary

Objective and background: The aim of this study is to evaluate the clinical outcome of using the hyaluronic acid gel in reconstructing inter-dental papillae at the aesthetic zones in a follow-up period of six months. Materials and Methods: 30 interdental papilla deficiencies which would meet the the inclusion criteria will be evaluated. After applying local anesthesia, 0.2 ml hyaluronic acid gel will be injected at the affected areas. This procedure will be repeated 3 times for the evaluated areas. Photographs will be taken before injection this material, and at 3 and 6 months following the intervention.

Detailed description

The presence or absence of the interproximal papilla is essential concern to periodontists, restorative dentists, and to the patients. The loss of papilla can cause cosmetic deformities (black triangles), phonetic problems, and food debris accumulation. Often the loss of papilla is a consequence of periodontal disease because of gingival inflammation, attachment loss and interproximal bone height resorption. Several reasons also lead to absence of interdental papillae including: 1\) Plaque associated lesions, 2) Traumatic oral hygiene procedures, 3) Abnormal tooth shape, 4) Improper contours of the restoration, 5) Spacing between teeth, 6) Loss of teeth.

Interventions

None listed

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

The patient should be: * 20-35 years old. * Healthy with no systemic diseases. * Non-smoker and non-alcoholic. * with good oral hygiene. * with healthy periodontal tissues. * suffering from one defected interdental papilla at least. Defected interdental papilla criteria: * Class 2 according to Jemt Classification (Jemt 1997). * The contact points between the teeth should be present. * There are no restorations or caries in the adjacent teeth. * The distance between the contact point and the interdental bone crest ≤ 6mm assessed radiographically.

Exclusion criteria

* History of allergic reaction to Hyaluronic acid * Parafunctional habits. * Traumatic occlusion. * The patient under orthodontic treatment. * Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of change in papillary height (PCPH) from baseline measurementT0: baseline assessment, T1: immed. following injection, T2: after 3 weeks, T3: immed. following 2nd injection if required, T4: after 6 weeks from T1, T5: immed. following 3rd injection if needed, T6: after 3 months, T7: after 6 months postoperatively.The treated sites will be examined, defect measurements will be recorded, and photographs will be taken at a standard (1:1) magnification. The measurement of the distance from the tip of the interdental papilla to the base of the contact area for each study lesion separately using specific software.

Secondary

MeasureTime frameDescription
Change in the Interdental Papilla Index Score (CPIS) from baseline measurementT0: baseline assessment, T1: immed. following injection, T2: after 3 weeks, T3: immed. following 2nd injection if required, T4: after 6 weeks from T1, T5: immed. following 3rd injection if needed, T6: after 3 months, T7: after 6 months postoperatively.The treated sites will be examined clinically, using a periodontal probe

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026