Chronic Periodontitis With Infra-bony DefectsNCT02170857
Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets
A study testing Hyaluronic Acid in people with Chronic Periodontitis With Infra-bony Defects, run by Damascus University at 1 site in Syria.
Trial summary
The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of periodontal pockets in people with gum disease. This research consists of clinical and radiographic studies. Participants should have symmetric periodontal pockets in the upper or lower jaw. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Chronic Periodontitis With Infra-bony Defects
- What is being tested?
- Hyaluronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- Jun 2014to Feb 2017
- Phase
- Interventional
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic periodontitis
- Symmetric Infra-bony defects with periodontal pocket depth more than 6 mm.
- in upper or lower premolar area.
- All participants will be collected from patients attending department of Periodontology - faculty of dentistry for periodontal disease treatment.
- Males and females.
- 35-65 years old.
- Systematically healthy.
- Accepting to participate in the study. Informed written consent will be required.
Who cannot join
- A history of previous scaling and root planning in the last 6 months
- Smokers
- Pregnant women
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Periodontics, University of Damascus Dental School
Damascus, DM20AM18
About this study
Official title: A Randomized Controlled Trial to Evaluate the Effect of Hyaluronic Acid on Infra-bony Defects: A Radiographic and Clinical Study.
The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of periodontal pockets in people with gum disease.
This research consists of clinical and radiographic studies. Participants should have symmetric periodontal pockets in the upper or lower jaw.
Participants will be treated surgically using hyaluronic acid on one side of the jaw.
Clinical indexes and radiographic cone-beam computed tomographic (CBCT) images will be taken for each participant before surgical treatment and 12 months after surgical treatment.
Read the detailed description
The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of infra-bony pockets in chronic periodontitis patients.
This research consists of clinical and radiographic studies.
1- The clinical study: is a randomized controlled trial with a split mouth technique.
Chronic periodontitis patients with Infra-bony pockets will be collected from the Department of Periodontics in faculty of dentistry - Damascus university.
Participants should have symmetric infra-bony pockets in the upper or lower premolar area with pocket probing depth more than 6 mm.
Participants will be treated surgically using open flap curettage.
Open flap curettage will be done for each patient in both sides of the jaw, but hyaluronic acid will be used in one of the two sides with random allocation of the site that in going to be treated with hyaluronic acid.
Plaque index, gingival index, bleeding on probing, tooth mobility index, pocket probing depth and clinical attachment loss will be taken for each participant four times; before surgical treatment, 3 months, six months and 12 months after surgical treatment.
Radiographic study: will be done using CBCT radiography technique. CBCT will be taken for each participant before and after 12 months of surgical treatment. Different distances, vertical bone fill and depth of infra-bony defect will be measured on CBCT images.
- Being tested
- Hyaluronic Acid
- Keywords
- Hyaluronic acid, infra-bony defects, chronic periodontitis, experimental, radiographic, clinical, periodontal surgical treatment, open flap curettage
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
This material will be used in conjunction with the ordinary surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Open Curettage Only | No intervention | patients will be treated by the conventional surgical method, i.e. open curettage without injecting any material. |
| Open Curettage with Hyaluronic Acid | Experimental | Hyaluronic Acid injection will be employed in conjunction with the ordinary surgical procedure. Receives: Drug: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Clinical Attachment Loss (CAL)
Clinical Attachment Loss (CAL): it is the distance between the cement-enamel junction of the tooth and the bottom of the pocket.
CAL will be performed using a dental probe.
Measured: CAL will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery
Vertical bone fill
Vertical bone fill: it is the distance between the base of the infra-bony defect and cement-enamel junction before surgery minus the distance between base of the infra-bony defect and cement enamel junction after surgery.
It will be measured on CBCT images.
Measured: at 12 months post-surgery
Secondary outcomes (4)
Change in the Pocket Probing Depth (PPD)
Pocket Probing Depth (PPD): it is the distance from the gingival margin to the bottom of the pocket at four sites per tooth. PPD will be measured using a dental probe.
Measured: PPD will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery
Buccolingual distance
Buccolingual distance: is the distance between buccal wall and lingual wall of the infra-bony pocket.
Measured: at 12 months post-surgery
Mesiodistal distance
Mesiodistal distance: is the distance between mesial wall and distal wall of the infra-bony pocket.
Measured: at 12 months post-surgery
Depth of infra-bony defect
Depth of infra-bony defect: is the distance between the base of the infra-bony defect and the most coronal level of alveolar crest.
Measured: at 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Periodontitis With Infra-bony DefectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lina Bashour, DDS MSc, Principal investigator, PhD student, Department of Periodontics, University of Damascus Dental School, DamascusRazan Khattab, DDS MSc PhD, Study director, Professor of Periodontics, Dean of the Dental School, University of Damascus Dental School, Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170857
- Sponsor's protocol ID
- UDDS-Perio-05-2014
- Status last verified
- Jul 2017
- First submitted
- 20 Jun 2014
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baldini A, Zaffe D, Nicolini G. Bone-defects healing by high-molecular hyaluronic acid: preliminary results. Ann Stomatol (Roma). 2010 Jan;1(1):2-7. Epub 2010 Jun 29.
PubMed 22238698Ballini A, Cantore S, Capodiferro S, Grassi FR. Esterified hyaluronic acid and autologous bone in the surgical correction of the infra-bone defects. Int J Med Sci. 2009;6(2):65-71. doi: 10.7150/ijms.6.65. Epub 2009 Feb 26.
PubMed 19277251Bansal J, Kedige SD, Anand S. Hyaluronic acid: a promising mediator for periodontal regeneration. Indian J Dent Res. 2010 Oct-Dec;21(4):575-8. doi: 10.4103/0970-9290.74232.
PubMed 21187628Briguglio F, Briguglio E, Briguglio R, Cafiero C, Isola G. Treatment of infrabony periodontal defects using a resorbable biopolymer of hyaluronic acid: a randomized clinical trial. Quintessence Int. 2013 Mar;44(3):231-40. doi: 10.3290/j.qi.a29054.
PubMed 23444204Vanden Bogaerde L. Treatment of infrabony periodontal defects with esterified hyaluronic acid: clinical report of 19 consecutive lesions. Int J Periodontics Restorative Dent. 2009 Jun;29(3):315-23.
PubMed 19537471Gontiya G, Galgali SR. Effect of hyaluronan on periodontitis: A clinical and histological study. J Indian Soc Periodontol. 2012 Apr;16(2):184-92. doi: 10.4103/0972-124X.99260.
PubMed 23055583
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effect of Hyaluronic Acid on Infra-bony Defects: A Radiographic and Clinical Study.
- ClinicalTrials.gov ID
- NCT02170857
- Acronym / sponsor ID
- UDDS-Perio-05-2014
- Keywords
- Hyaluronic acid, infra-bony defects, chronic periodontitis, experimental, radiographic, clinical, periodontal surgical treatment, open flap curettage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Jun 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.
The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of periodontal pockets in people with gum disease.
This research consists of clinical and radiographic studies. Participants should have symmetric periodontal pockets in the upper or lower jaw.
Participants will be treated surgically using hyaluronic acid on one side of the jaw.
Clinical indexes and radiographic cone-beam computed tomographic (CBCT) images will be taken for each participant before surgical treatment and 12 months after surgical treatment.
Detailed description
The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of infra-bony pockets in chronic periodontitis patients.
This research consists of clinical and radiographic studies.
1- The clinical study: is a randomized controlled trial with a split mouth technique.
Chronic periodontitis patients with Infra-bony pockets will be collected from the Department of Periodontics in faculty of dentistry - Damascus university.
Participants should have symmetric infra-bony pockets in the upper or lower premolar area with pocket probing depth more than 6 mm.
Participants will be treated surgically using open flap curettage.
Open flap curettage will be done for each patient in both sides of the jaw, but hyaluronic acid will be used in one of the two sides with random allocation of the site that in going to be treated with hyaluronic acid.
Plaque index, gingival index, bleeding on probing, tooth mobility index, pocket probing depth and clinical attachment loss will be taken for each participant four times; before surgical treatment, 3 months, six months and 12 months after surgical treatment.
Radiographic study: will be done using CBCT radiography technique. CBCT will be taken for each participant before and after 12 months of surgical treatment. Different distances, vertical bone fill and depth of infra-bony defect will be measured on CBCT images.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Curettage Only | No intervention | –patients will be treated by the conventional surgical method, i.e. open curettage without injecting any material. |
| Open Curettage with Hyaluronic Acid | Experimental | Drug: Hyaluronic AcidHyaluronic Acid injection will be employed in conjunction with the ordinary surgical procedure. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with chronic periodontitis
- Symmetric Infra-bony defects with periodontal pocket depth more than 6 mm.
- in upper or lower premolar area.
- All participants will be collected from patients attending department of Periodontology - faculty of dentistry for periodontal disease treatment.
- Males and females.
Key exclusion criteria (4 listed)
- A history of previous scaling and root planning in the last 6 months
- Smokers
- Pregnant women
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic AcidThis material will be used in conjunction with the ordinary surgical procedure | Drug | Open Curettage with Hyaluronic Acid |
Primary outcome
Change in the Clinical Attachment Loss (CAL)
Time frame: CAL will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery
Clinical Attachment Loss (CAL): it is the distance between the cement-enamel junction of the tooth and the bottom of the pocket. CAL will be performed using a dental probe.
Vertical bone fill
Time frame: at 12 months post-surgery
Vertical bone fill: it is the distance between the base of the infra-bony defect and cement-enamel junction before surgery minus the distance between base of the infra-bony defect and cement enamel junction after surgery. It will be measured on CBCT images.
4 secondary outcomes
Change in the Pocket Probing Depth (PPD)
Time frame: PPD will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery
Buccolingual distance
Time frame: at 12 months post-surgery
Mesiodistal distance
Time frame: at 12 months post-surgery
Depth of infra-bony defect
Time frame: at 12 months post-surgery
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 27 Jul 2017.
- Background: PubMed 22238698Baldini A, Zaffe D, Nicolini G. Bone-defects healing by high-molecular hyaluronic acid: preliminary results. Ann Stomatol (Roma). 2010 Jan;1(1):2-7. Epub 2010 Jun 29.
- Background: PubMed 19277251Ballini A, Cantore S, Capodiferro S, Grassi FR. Esterified hyaluronic acid and autologous bone in the surgical correction of the infra-bone defects. Int J Med Sci. 2009;6(2):65-71. doi: 10.7150/ijms.6.65. Epub 2009 Feb 26.
- Background: PubMed 21187628Bansal J, Kedige SD, Anand S. Hyaluronic acid: a promising mediator for periodontal regeneration. Indian J Dent Res. 2010 Oct-Dec;21(4):575-8. doi: 10.4103/0970-9290.74232.
- Background: PubMed 23444204Briguglio F, Briguglio E, Briguglio R, Cafiero C, Isola G. Treatment of infrabony periodontal defects using a resorbable biopolymer of hyaluronic acid: a randomized clinical trial. Quintessence Int. 2013 Mar;44(3):231-40. doi: 10.3290/j.qi.a29054.
- Background: PubMed 19537471Vanden Bogaerde L. Treatment of infrabony periodontal defects with esterified hyaluronic acid: clinical report of 19 consecutive lesions. Int J Periodontics Restorative Dent. 2009 Jun;29(3):315-23.
- Background: PubMed 23055583Gontiya G, Galgali SR. Effect of hyaluronan on periodontitis: A clinical and histological study. J Indian Soc Periodontol. 2012 Apr;16(2):184-92. doi: 10.4103/0972-124X.99260.
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.
Lina Bashour, DDS MSc principal investigator
PhD student, Department of Periodontics, University of Damascus Dental School, Damascus
Razan Khattab, DDS MSc PhD study director
Professor of Periodontics, Dean of the Dental School, 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?
A study testing Hyaluronic Acid in people with Chronic Periodontitis With Infra-bony Defects, 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 8 inclusion and 4 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 27 Jul 2017. 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?
Change in the Clinical Attachment Loss (CAL) (time frame: CAL will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery). The study lists 2 primary outcomes in all. 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 NCT02170857, which also lists 6 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 27 Jul 2017.