Clinical trial NCT02119741: Reconstruction of Interdental Papilla Using Hyaluronic Acid
Official title: The Role of Hyaluronic Acid in Reconstruction of Interdental Papilla in The Esthetic Zone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Defected Interdental Papilla
Keywords: Interdental papilla
hyaluronic acid
esthetic zone
black triangles
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from the database of Periodontics Department at University of Damascus. A random sample of 30 patients will be included in this evaluation study from those who have been identified with defected interdental papillae.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of change in papillary height (PCPH) from baseline measurement
timeFrame: T0: 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.
Secondary outcomes:
measure: Change in the Interdental Papilla Index Score (CPIS) from baseline measurement
timeFrame: T0: 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.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Periodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student, Department of Periodontology, University of Damascus Dental School
name: Tarek Ata Dalal, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus
name: Suleiman Dayoub, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: Agudio G, Pini Prato GP, Nevins M, Cortellini P, Ono Y. Esthetic modifications in periodontal therapy. Int J Periodontics Restorative Dent. 1989;9(4):288-99. No abstract available.
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citation: Angelopoulos AP, Goaz PW. Incidence of diphenylhydantoin gingival hyperplasia. Oral Surg Oral Med Oral Pathol. 1972 Dec;34(6):898-906. doi: 10.1016/0030-4220(72)90228-9. No abstract available.
citation: Becker W, Gabitov I, Stepanov M, Kois J, Smidt A, Becker BE. Minimally invasive treatment for papillae deficiencies in the esthetic zone: a pilot study. Clin Implant Dent Relat Res. 2010 Mar;12(1):1-8. doi: 10.1111/j.1708-8208.2009.00247.x. Epub 2009 Oct 16.
citation: Biesman B. Soft tissue augmentation using Restylane. Facial Plast Surg. 2004 May;20(2):171-7; discussion 178-9. doi: 10.1055/s-2004-861760.
citation: Brandt FS, Cazzaniga A. Hyaluronic acid fillers: Restylane and Perlane. Facial Plast Surg Clin North Am. 2007 Feb;15(1):63-76, vii. doi: 10.1016/j.fsc.2006.11.002.
citation: Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.