Reconstruction of Interdental Papilla Using Hyaluronic Acid

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

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.

Study Overview

• Status: Completed
• Conditions: Defected Interdental Papilla

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Department of Periodontics, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Affected Interdental Papillae Group; This is the only group in which the material will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of change in papillary height (PCPH) from baseline measurement	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Interdental Papilla Index Score (CPIS) from baseline measurement	The treated sites will be examined clinically, using a periodontal probe	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.

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Tarek Ata Dalal, DDS, MSc student, Department of Periodontology, University of Damascus Dental School; Study Director: Suleiman Dayoub, DDS MSc PhD, Associate Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus

Publications and helpful links

General Publications

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
• 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.
• 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.
• 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.
• 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.
• 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.
• Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: April 18, 2014
• First Submitted That Met QC Criteria: April 21, 2014
• First Posted (Estimate): April 22, 2014

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 2, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: hyaluronic acid; Interdental papilla; esthetic zone; black triangles
• Other Study ID Numbers: UDDS-Perio-02-2014