Defected Interdental PapillaNCT02119741
Reconstruction of Interdental Papilla Using Hyaluronic Acid
An observational study of Defected Interdental Papilla, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Defected Interdental Papilla
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- May 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- History of allergic reaction to Hyaluronic acid
- Parafunctional habits.
- Traumatic occlusion.
- The patient under orthodontic treatment.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Periodontics, University of Damascus Dental School
Damascus, Rif-dimashq Governorate, DM20AM18
About this study
Official title: 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.
Read the 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:
- 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
- Defected Interdental Papilla
- Keywords
- Interdental papilla, hyaluronic acid, esthetic zone, black triangles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected Interdental Papillae Group | This is the only group in which the material will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
Change in the Interdental Papilla Index Score (CPIS) from baseline measurement
The treated sites will be examined clinically, using a periodontal probe
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Defected Interdental PapillaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek Ata Dalal, DDS, Principal investigator, MSc student, Department of Periodontology, University of Damascus Dental SchoolSuleiman Dayoub, DDS MSc PhD, Study director, Associate Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119741
- Sponsor's protocol ID
- UDDS-Perio-02-2014
- Status last verified
- Oct 2015
- First submitted
- 18 Apr 2014
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 2640208Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
PubMed 1058834Angelopoulos 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.
PubMed 4509004Becker 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.
PubMed 19843105Biesman B. Soft tissue augmentation using Restylane. Facial Plast Surg. 2004 May;20(2):171-7; discussion 178-9. doi: 10.1055/s-2004-861760.
PubMed 15643586Brandt 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.
PubMed 17317557Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.
PubMed 9497723
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Hyaluronic Acid in Reconstruction of Interdental Papilla in The Esthetic Zone
- ClinicalTrials.gov ID
- NCT02119741
- Acronym / sponsor ID
- UDDS-Perio-02-2014
- Conditions
- Defected Interdental Papilla
- Keywords
- Interdental papilla, hyaluronic acid, esthetic zone, black triangles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Affected Interdental Papillae Group | – | –This is the only group in which the material will be used |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (12 listed)
- 20-35 years old.
- Healthy with no systemic diseases.
- Non-smoker and non-alcoholic.
- with good oral hygiene.
- with healthy periodontal tissues.
Key exclusion criteria (5 listed)
- History of allergic reaction to Hyaluronic acid
- Parafunctional habits.
- Traumatic occlusion.
- The patient under orthodontic treatment.
- Pregnant and lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of change in papillary height (PCPH) from baseline measurement
Time frame: 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.
1 secondary outcome
Change in the Interdental Papilla Index Score (CPIS) from baseline measurement
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Background: PubMed 2640208Agudio 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.
- Background: PubMed 1058834Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
- Background: PubMed 4509004Angelopoulos 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.
- Background: PubMed 19843105Becker 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.
- Background: PubMed 15643586Biesman B. Soft tissue augmentation using Restylane. Facial Plast Surg. 2004 May;20(2):171-7; discussion 178-9. doi: 10.1055/s-2004-861760.
- Background: PubMed 17317557Brandt 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.
- Background: PubMed 9497723Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Ata Dalal, DDS principal investigator
MSc student, Department of Periodontology, University of Damascus Dental School
Suleiman Dayoub, DDS MSc PhD study director
Associate Professor of Periodontics, Department of Periodontics, University of Damascus Dental School, Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Defected Interdental Papilla, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of change in papillary height (PCPH) from baseline measurement (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02119741, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.