Reconstruction of Interdental Papilla Using Hyaluronic Acid

Completed

• Conditions: Defected Interdental Papilla

• Registration Number: NCT02119741
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-22
• Study Start: 2014-05
• Primary Completion: 2015-03
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-02
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of change in papillary height (PCPH) from baseline measurement	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.	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Periodontics, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic