PeriodontitisPhase 4NCT03311906
Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel
A Phase 4 study testing 0.8% Hyaluronic Acid and Scaling and Root Planing in people with Periodontitis, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
assess the clinical and laboratory effects of the local and sub gingival application of a 0.8% hyaluronic acid gel (GENGIGEL®) as an adjunct to scaling and root planning (SRP) in chronic moderate to severe periodontitis patients as indicated by expression of Human Beta Definsin-2 (HBD2) in gingival crevicular fluid… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- 0.8% Hyaluronic Acid and Scaling and Root Planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Feb 2017to 2 Oct 2017
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients should be systemically healthy with moderate to severe chronic periodontitis of more than 4 mm probing depth in at least two sites in different quadrants.
- Patient should exhibit no known allergies
- Participants should have the ability to attend the hospital regular intervals.
Who cannot join
- pregnancy
- nursing
- hypertension
- patient with chronic diseases such as diabetes mellitus or rheumatoid arthritis. -Participants should not be under antibiotics and\or had receive any periodontal therapy for the last 6 months.
- Participants should not taking drugs that could affect the state of the gingival tissues.
- Participants must not be undergoing orthodontic therapy, caries free
- Participants must not be using any other supplemental plaque control measures like mouthwashes.
- Participants should not have the habit of taking alcohol, smoking or chewing tobacco and do not suffer from any systemic disease.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, AlRiyadh, 11681
About this study
Official title: Clinical and Laboratory Effect of 0.8% Hyaluronic Acid Gel in Conventional Treatment of Moderate to Severe Chronic Periodontitis
assess the clinical and laboratory effects of the local and sub gingival application of a 0.8% hyaluronic acid gel (GENGIGEL®) as an adjunct to scaling and root planning (SRP) in chronic moderate to severe periodontitis patients as indicated by expression of Human Beta Definsin-2 (HBD2) in gingival crevicular fluid (GCF).
Read the detailed description
Patients who fulfilled the selection criteria will be included in the study. One quadrant will be treated with HA gel (test) and the other without to serve as control. Clinical examination will be done in a dental chair under standard conditions of light, using mouth mirror and graduated Williams Periodontal Probe.
All patients will receive full mouth scaling and root planing with hand instruments and ultrasonic scalers at baseline. Thereafter, in the test quadrant, 1 ml of 0.8% hyaluronic acid gel will be administered subgingivally in all selected test sites at baseline and 1 week later. The following clinical parameters will be recorded at baseline, after 6 weeks and 12 weeks post treatment. Oral hygiene instructions will be given to all patients. The clinical measurements and treatment will be performed by a single examiner.For every patient and control subject, GCF samples will be collected at baseline, 6 weeks and 12 weeks post treatment. The samples will be pooled from two periodontal sites with clinical attachment level of 3 mm or more (in the two different quadrants). The sampling area will be isolated with cotton rolls and carefully will be cleaned supragingivally with sterile cotton pellets. A sterile absorbent paper point will be inserted into the gingival crevice or pocket until resistance will be felt. The paper point will be held in place for 30 s and then will be transferred to a vial containing 100 μL of distilled water and vigorously will be mixed. The paper points will be removed, and the samples will be centrifuged and will be washed twice with distilled water. The resultant pellets will be resuspended in 0.4 mL of distilled water. The samples will be coded and stored at -70 °C until use for ELISA test for identification of Human beta Defensin-2.
- Conditions
- Periodontitis
- Being tested
- 0.8% Hyaluronic Acid, Scaling and Root Planing
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.8% Hyaluronic AcidDrug
Also called Gengigel
Application of 0.8% hyaluronic acid after scaling and root planing
Scaling and Root PlaningProcedure or surgery
Scaling of the teeth using hand and ultrasonic scalers followed by planing of the root with curettes
| Study group | Role | What they receive |
|---|---|---|
| Test side | Experimental | Scaling and Root Planing 0.8% Hyaluronic acid gel Receives: Drug: 0.8% Hyaluronic Acid; Procedure: Scaling and Root Planing |
| Control Side | Active comparator | Scaling and Root Planing Receives: Procedure: Scaling and Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level (CAL) change
Distance from the cementoenamel junction to the base of gingival sulcus using a UNC15 probe
Measured: baseline, six weeks, 12 weeks
Probing Depth change
It's the distance from the gingival margin to base of the sulcus
Measured: baseline, six weeks, 12 weeks
Gingival Index change (Loe and Silness, 1963)
To assess the gingival condition and record qualitative chances in the gingiva
Measured: baseline, six weeks, 12 weeks
Plaque index change (Loe and Silness, 1964)
To measure the state of oral hygiene
Measured: baseline, six weeks, 12 weeks
Papillary Bleeding Index change (Muhlemann, 1977)
immediate evaluation of the patient's gingival motivation and condition
Measured: baseline, six weeks, 12 weeks
Secondary outcomes (1)
HBD-2 change
By take gingival crevicular fluid sample elisa test
Measured: baseline, six weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start15 Feb 2017
- Primary completion15 Aug 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A split mouth study design is used where all participants receive both interventions
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Al Shammari, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Sanaa M Shafshak, PhD, Study director, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311906
- Sponsor's protocol ID
- FPGRP/43631003/73
- Status last verified
- Mar 2018
- First submitted
- 2 Oct 2017
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brogden KA. Antimicrobial peptides: pore formers or metabolic inhibitors in bacteria? Nat Rev Microbiol. 2005 Mar;3(3):238-50. doi: 10.1038/nrmicro1098.
PubMed 15703760Diamond DL, Kimball JR, Krisanaprakornkit S, Ganz T, Dale BA. Detection of beta-defensins secreted by human oral epithelial cells. J Immunol Methods. 2001 Oct 1;256(1-2):65-76. doi: 10.1016/s0022-1759(01)00442-2.
PubMed 11516756Embery G, Waddington RJ, Hall RC, Last KS. Connective tissue elements as diagnostic aids in periodontology. Periodontol 2000. 2000 Oct;24:193-214. doi: 10.1034/j.1600-0757.2000.2240109.x. No abstract available.
PubMed 11276867Garcia JR, Jaumann F, Schulz S, Krause A, Rodriguez-Jimenez J, Forssmann U, Adermann K, Kluver E, Vogelmeier C, Becker D, Hedrich R, Forssmann WG, Bals R. Identification of a novel, multifunctional beta-defensin (human beta-defensin 3) with specific antimicrobial activity. Its interaction with plasma membranes of Xenopus oocytes and the induction of macrophage chemoattraction. Cell Tissue Res. 2001 Nov;306(2):257-64. doi: 10.1007/s004410100433.
PubMed 11702237Gontiya 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 23055583Gorr SU. Antimicrobial peptides in periodontal innate defense. Front Oral Biol. 2012;15:84-98. doi: 10.1159/000329673. Epub 2011 Nov 11.
PubMed 22142958Gorr SU, Abdolhosseini M. Antimicrobial peptides and periodontal disease. J Clin Periodontol. 2011 Mar;38 Suppl 11:126-41. doi: 10.1111/j.1600-051X.2010.01664.x.
PubMed 21323710Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000. 1994 Jun;5:78-111. doi: 10.1111/j.1600-0757.1994.tb00020.x. No abstract available.
PubMed 9673164Heitz-Mayfield LJ. How effective is surgical therapy compared with nonsurgical debridement? Periodontol 2000. 2005;37:72-87. doi: 10.1111/j.1600-0757.2004.03797.x. No abstract available.
PubMed 15655026Jentsch H, Pomowski R, Kundt G, Gocke R. Treatment of gingivitis with hyaluronan. J Clin Periodontol. 2003 Feb;30(2):159-64. doi: 10.1034/j.1600-051x.2003.300203.x.
PubMed 12622859Johannsen A, Tellefsen M, Wikesjo U, Johannsen G. Local delivery of hyaluronan as an adjunct to scaling and root planing in the treatment of chronic periodontitis. J Periodontol. 2009 Sep;80(9):1493-7. doi: 10.1902/jop.2009.090128.
PubMed 19722800Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
PubMed 5237684LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956Moseley R, Waddington RJ, Embery G. Hyaluronan and its potential role in periodontal healing. Dent Update. 2002 Apr;29(3):144-8. doi: 10.12968/denu.2002.29.3.144.
PubMed 11989392Muhlemann HR. Psychological and chemical mediators of gingival health. J Prev Dent. 1977 Jul-Aug;4(4):6-17. No abstract available.
PubMed 275483
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Effect of 0.8% Hyaluronic Acid Gel in Conventional Treatment of Moderate to Severe Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03311906
- Acronym / sponsor ID
- FPGRP/43631003/73
- Conditions
- Periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 17 Oct 2017 (actual)
- 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.
assess the clinical and laboratory effects of the local and sub gingival application of a 0.8% hyaluronic acid gel (GENGIGEL®) as an adjunct to scaling and root planning (SRP) in chronic moderate to severe periodontitis patients as indicated by expression of Human Beta Definsin-2 (HBD2) in gingival crevicular fluid (GCF).
Detailed description
Patients who fulfilled the selection criteria will be included in the study. One quadrant will be treated with HA gel (test) and the other without to serve as control. Clinical examination will be done in a dental chair under standard conditions of light, using mouth mirror and graduated Williams Periodontal Probe.
All patients will receive full mouth scaling and root planing with hand instruments and ultrasonic scalers at baseline. Thereafter, in the test quadrant, 1 ml of 0.8% hyaluronic acid gel will be administered subgingivally in all selected test sites at baseline and 1 week later. The following clinical parameters will be recorded at baseline, after 6 weeks and 12 weeks post treatment. Oral hygiene instructions will be given to all patients. The clinical measurements and treatment will be performed by a single examiner.For every patient and control subject, GCF samples will be collected at baseline, 6 weeks and 12 weeks post treatment. The samples will be pooled from two periodontal sites with clinical attachment level of 3 mm or more (in the two different quadrants). The sampling area will be isolated with cotton rolls and carefully will be cleaned supragingivally with sterile cotton pellets. A sterile absorbent paper point will be inserted into the gingival crevice or pocket until resistance will be felt. The paper point will be held in place for 30 s and then will be transferred to a vial containing 100 μL of distilled water and vigorously will be mixed. The paper points will be removed, and the samples will be centrifuged and will be washed twice with distilled water. The resultant pellets will be resuspended in 0.4 mL of distilled water. The samples will be coded and stored at -70 °C until use for ELISA test for identification of Human beta Defensin-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A split mouth study design is used where all participants receive both interventions
| Arm | Type | Receives |
|---|---|---|
| Test side | Experimental | Drug: 0.8% Hyaluronic Acid, Procedure: Scaling and Root PlaningScaling and Root Planing 0.8% Hyaluronic acid gel |
| Control Side | Active comparator | Procedure: Scaling and Root PlaningScaling and Root Planing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients should be systemically healthy with moderate to severe chronic periodontitis of more than 4 mm probing depth in at least two sites in different quadrants.
- Patient should exhibit no known allergies
- Participants should have the ability to attend the hospital regular intervals.
Key exclusion criteria (8 listed)
- pregnancy
- nursing
- hypertension
- patient with chronic diseases such as diabetes mellitus or rheumatoid arthritis. -Participants should not be under antibiotics and\or had receive any periodontal therapy for the last 6 months.
- Participants should not taking drugs that could affect the state of the gingival tissues.
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 |
|---|---|---|
| 0.8% Hyaluronic AcidAlso: GengigelApplication of 0.8% hyaluronic acid after scaling and root planing | Drug | Test side |
| Scaling and Root PlaningScaling of the teeth using hand and ultrasonic scalers followed by planing of the root with curettes | Procedure or surgery | Control Side, Test side |
Primary outcome
Clinical Attachment Level (CAL) change
Time frame: baseline, six weeks, 12 weeks
Distance from the cementoenamel junction to the base of gingival sulcus using a UNC15 probe
Probing Depth change
Time frame: baseline, six weeks, 12 weeks
It's the distance from the gingival margin to base of the sulcus
Gingival Index change (Loe and Silness, 1963)
Time frame: baseline, six weeks, 12 weeks
To assess the gingival condition and record qualitative chances in the gingiva
Plaque index change (Loe and Silness, 1964)
Time frame: baseline, six weeks, 12 weeks
To measure the state of oral hygiene
Papillary Bleeding Index change (Muhlemann, 1977)
Time frame: baseline, six weeks, 12 weeks
immediate evaluation of the patient's gingival motivation and condition
1 secondary outcome
HBD-2 change
Time frame: baseline, six weeks, 12 weeks
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 Mar 2018.
- Results publication: PubMed 15703760Brogden KA. Antimicrobial peptides: pore formers or metabolic inhibitors in bacteria? Nat Rev Microbiol. 2005 Mar;3(3):238-50. doi: 10.1038/nrmicro1098.
- Results publication: PubMed 11516756Diamond DL, Kimball JR, Krisanaprakornkit S, Ganz T, Dale BA. Detection of beta-defensins secreted by human oral epithelial cells. J Immunol Methods. 2001 Oct 1;256(1-2):65-76. doi: 10.1016/s0022-1759(01)00442-2.
- Results publication: PubMed 11276867Embery G, Waddington RJ, Hall RC, Last KS. Connective tissue elements as diagnostic aids in periodontology. Periodontol 2000. 2000 Oct;24:193-214. doi: 10.1034/j.1600-0757.2000.2240109.x. No abstract available.
- Results publication: PubMed 11702237Garcia JR, Jaumann F, Schulz S, Krause A, Rodriguez-Jimenez J, Forssmann U, Adermann K, Kluver E, Vogelmeier C, Becker D, Hedrich R, Forssmann WG, Bals R. Identification of a novel, multifunctional beta-defensin (human beta-defensin 3) with specific antimicrobial activity. Its interaction with plasma membranes of Xenopus oocytes and the induction of macrophage chemoattraction. Cell Tissue Res. 2001 Nov;306(2):257-64. doi: 10.1007/s004410100433.
- Results publication: 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.
- Results publication: PubMed 22142958Gorr SU. Antimicrobial peptides in periodontal innate defense. Front Oral Biol. 2012;15:84-98. doi: 10.1159/000329673. Epub 2011 Nov 11.
- Results publication: PubMed 21323710Gorr SU, Abdolhosseini M. Antimicrobial peptides and periodontal disease. J Clin Periodontol. 2011 Mar;38 Suppl 11:126-41. doi: 10.1111/j.1600-051X.2010.01664.x.
- Results publication: PubMed 9673164Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000. 1994 Jun;5:78-111. doi: 10.1111/j.1600-0757.1994.tb00020.x. No abstract available.
- Results publication: PubMed 15655026Heitz-Mayfield LJ. How effective is surgical therapy compared with nonsurgical debridement? Periodontol 2000. 2005;37:72-87. doi: 10.1111/j.1600-0757.2004.03797.x. No abstract available.
- Results publication: PubMed 12622859Jentsch H, Pomowski R, Kundt G, Gocke R. Treatment of gingivitis with hyaluronan. J Clin Periodontol. 2003 Feb;30(2):159-64. doi: 10.1034/j.1600-051x.2003.300203.x.
- Results publication: PubMed 19722800Johannsen A, Tellefsen M, Wikesjo U, Johannsen G. Local delivery of hyaluronan as an adjunct to scaling and root planing in the treatment of chronic periodontitis. J Periodontol. 2009 Sep;80(9):1493-7. doi: 10.1902/jop.2009.090128.
- Results publication: PubMed 5237684Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
- Individual participant dataSharing planned: No
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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.
Sanaa M Shafshak, PhD study director
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.8% Hyaluronic Acid and Scaling and Root Planing in people with Periodontitis, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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 3 inclusion and 8 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 Mar 2018. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical Attachment Level (CAL) change (time frame: baseline, six weeks, 12 weeks). The study lists 5 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 NCT03311906, which also lists 22 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 Mar 2018.