Reconstruction of Interdental Papilla Using Hyaluronic Acid

NCT ID: NCT02119741

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Defected Interdental Papilla

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Affected Interdental Papillae Group

This is the only group in which the material will be used

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tarek Ata Dalal, DDS

Role: PRINCIPAL_INVESTIGATOR

MSc student, Department of Periodontology, University of Damascus Dental School

Suleiman Dayoub, DDS MSc PhD

Role: STUDY_DIRECTOR

Associate Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus

Locations

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Department of Periodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 2640208 (View on PubMed)

Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

Reference Type BACKGROUND
PMID: 1058834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4509004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19843105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15643586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17317557 (View on PubMed)

Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.

Reference Type BACKGROUND
PMID: 9497723 (View on PubMed)

Other Identifiers

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UDDS-Perio-02-2014

Identifier Type: -

Identifier Source: org_study_id

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