Chronic PeriodontitisNCT02160613
Osteoprotegerin Before and After Periodontal Surgery
A study testing Open flap debridement in people with Chronic Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
The study hypothesis: Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease? Read more about this study
- Who is it for?
- Ages 32 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Open flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2013to Jan 2014
- 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 32 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- severe chronic periodontitis, having pocket depth of ≥ 5 mm and clinical attachment level ≥ 5 mm
Who cannot join
- pregnant women
- subjects had <22 permanent teeth
- having any given systemic disease
- taking any type of medication and/or antibiotic therapy during the 3 months before the study
- received periodontal treatment within the past 12 months
- current or former smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Periodontal Surgery on Osteoprotegerin Levels in Gingival Crevicular Fluid, Saliva and Gingival Tissues.
The study hypothesis:
Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?
Read the detailed description
assessment of osteoprotegerin in patients with chronic periodontitis before and after periodontal surgery in gingival crevicular fluid, saliva and gingival tissues.
- Conditions
- Chronic Periodontitis
- Being tested
- Open flap debridement
- Keywords
- Osteoprotegerin, Biomarker, Chronic periodontitis, Open flap debridement
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open flap debridementProcedure or surgery
an access flap
| Study group | Role | What they receive |
|---|---|---|
| Open flap for periodontitis patients | Other | Open flap debridement Receives: Procedure: Open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Osteoprotegerin levels at 3 and 6 months
Measured: Baseline, 3 months and 6 months
Secondary outcomes (4)
changes from baseline in Clinical attachment level at 3 and 6 months.
Measured: Baseline, 3 months and 6 months
Changes from baseline in probing pocket depth at 3 and 6 months
Measured: baseline, 3 months and 6 months
Changes from baseline in plaque index at 3 and 6 months
Measured: baseline, 3 months and 6 months
Changes from baseline in gingival index at 3 and 6 months
Measured: baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Mahmoud ElRefai, M.D., Study director, Professor of Oral Medicine and Periodontology , Faculty of oral and dental medicine Cairo Unv.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160613
- Sponsor's protocol ID
- OPG_OFD
- Status last verified
- Jun 2014
- First submitted
- 7 Jun 2014
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu D, Xu JK, Figliomeni L, Huang L, Pavlos NJ, Rogers M, Tan A, Price P, Zheng MH. Expression of RANKL and OPG mRNA in periodontal disease: possible involvement in bone destruction. Int J Mol Med. 2003 Jan;11(1):17-21. doi: 10.3892/ijmm.11.1.17.
PubMed 12469211Crotti T, Smith MD, Hirsch R, Soukoulis S, Weedon H, Capone M, Ahern MJ, Haynes D. Receptor activator NF kappaB ligand (RANKL) and osteoprotegerin (OPG) protein expression in periodontitis. J Periodontal Res. 2003 Aug;38(4):380-7. doi: 10.1034/j.1600-0765.2003.00615.x.
PubMed 12828654Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Toz H, Berdeli A, Atilla G, McKay IJ, Hughes FJ, Belibasakis GN. Differential expression of receptor activator of nuclear factor-kappaB ligand and osteoprotegerin mRNA in periodontal diseases. J Periodontal Res. 2007 Aug;42(4):287-93. doi: 10.1111/j.1600-0765.2006.00946.x.
PubMed 17559623Mogi M, Otogoto J, Ota N, Togari A. Differential expression of RANKL and osteoprotegerin in gingival crevicular fluid of patients with periodontitis. J Dent Res. 2004 Feb;83(2):166-9. doi: 10.1177/154405910408300216.
PubMed 14742657Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Toz H, Atilla G, Hughes FJ, Belibasakis GN. Gingival crevicular fluid levels of RANKL and OPG in periodontal diseases: implications of their relative ratio. J Clin Periodontol. 2007 May;34(5):370-6. doi: 10.1111/j.1600-051X.2007.01061.x. Epub 2007 Mar 13.
PubMed 17355365Buduneli N, Buduneli E, Kutukculer N. Interleukin-17, RANKL, and osteoprotegerin levels in gingival crevicular fluid from smoking and non-smoking patients with chronic periodontitis during initial periodontal treatment. J Periodontol. 2009 Aug;80(8):1274-80. doi: 10.1902/jop.2009.090106.
PubMed 19656027Costa PP, Trevisan GL, Macedo GO, Palioto DB, Souza SL, Grisi MF, Novaes AB Jr, Taba M Jr. Salivary interleukin-6, matrix metalloproteinase-8, and osteoprotegerin in patients with periodontitis and diabetes. J Periodontol. 2010 Mar;81(3):384-91. doi: 10.1902/jop.2009.090510.
PubMed 20192865Bostanci N, Saygan B, Emingil G, Atilla G, Belibasakis GN. Effect of periodontal treatment on receptor activator of NF-kappaB ligand and osteoprotegerin levels and relative ratio in gingival crevicular fluid. J Clin Periodontol. 2011 May;38(5):428-33. doi: 10.1111/j.1600-051X.2011.01701.x. Epub 2011 Jan 24.
PubMed 21261673Dereka XE, Markopoulou CE, Fanourakis G, Tseleni-Balafouta S, Vrotsos IA. RANKL and OPG mRNA level after non-surgical periodontal treatment. Inflammation. 2010 Jun;33(3):200-6. doi: 10.1007/s10753-009-9174-7.
PubMed 20033478Hassan SH, El-Refai MI, Ghallab NA, Kasem RF, Shaker OG. Effect of periodontal surgery on osteoprotegerin levels in gingival crevicular fluid, saliva, and gingival tissues of chronic periodontitis patients. Dis Markers. 2015;2015:341259. doi: 10.1155/2015/341259. Epub 2015 Feb 28.
PubMed 25814780
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Periodontal Surgery on Osteoprotegerin Levels in Gingival Crevicular Fluid, Saliva and Gingival Tissues.
- ClinicalTrials.gov ID
- NCT02160613
- Acronym / sponsor ID
- OPG_OFD
- Conditions
- Chronic Periodontitis
- Keywords
- Osteoprotegerin, Biomarker, Chronic periodontitis, Open flap debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 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 study hypothesis:
Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?
Detailed description
assessment of osteoprotegerin in patients with chronic periodontitis before and after periodontal surgery in gingival crevicular fluid, saliva and gingival tissues.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open flap for periodontitis patients | Other | Procedure: Open flap debridementOpen flap debridement |
Who may qualify
- Ages
- 32 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- severe chronic periodontitis, having pocket depth of ≥ 5 mm and clinical attachment level ≥ 5 mm
Key exclusion criteria (6 listed)
- pregnant women
- subjects had <22 permanent teeth
- having any given systemic disease
- taking any type of medication and/or antibiotic therapy during the 3 months before the study
- received periodontal treatment within the past 12 months
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 |
|---|---|---|
| Open flap debridementan access flap | Procedure or surgery | Open flap for periodontitis patients |
Primary outcome
Change from baseline in Osteoprotegerin levels at 3 and 6 months
Time frame: Baseline, 3 months and 6 months
4 secondary outcomes
changes from baseline in Clinical attachment level at 3 and 6 months.
Time frame: Baseline, 3 months and 6 months
Changes from baseline in probing pocket depth at 3 and 6 months
Time frame: baseline, 3 months and 6 months
Changes from baseline in plaque index at 3 and 6 months
Time frame: baseline, 3 months and 6 months
Changes from baseline in gingival index at 3 and 6 months
Time frame: baseline, 3 months and 6 months
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 10 Jun 2014.
- Results publication: PubMed 12469211Liu D, Xu JK, Figliomeni L, Huang L, Pavlos NJ, Rogers M, Tan A, Price P, Zheng MH. Expression of RANKL and OPG mRNA in periodontal disease: possible involvement in bone destruction. Int J Mol Med. 2003 Jan;11(1):17-21. doi: 10.3892/ijmm.11.1.17.
- Results publication: PubMed 12828654Crotti T, Smith MD, Hirsch R, Soukoulis S, Weedon H, Capone M, Ahern MJ, Haynes D. Receptor activator NF kappaB ligand (RANKL) and osteoprotegerin (OPG) protein expression in periodontitis. J Periodontal Res. 2003 Aug;38(4):380-7. doi: 10.1034/j.1600-0765.2003.00615.x.
- Results publication: PubMed 17559623Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Toz H, Berdeli A, Atilla G, McKay IJ, Hughes FJ, Belibasakis GN. Differential expression of receptor activator of nuclear factor-kappaB ligand and osteoprotegerin mRNA in periodontal diseases. J Periodontal Res. 2007 Aug;42(4):287-93. doi: 10.1111/j.1600-0765.2006.00946.x.
- Results publication: PubMed 14742657Mogi M, Otogoto J, Ota N, Togari A. Differential expression of RANKL and osteoprotegerin in gingival crevicular fluid of patients with periodontitis. J Dent Res. 2004 Feb;83(2):166-9. doi: 10.1177/154405910408300216.
- Results publication: PubMed 17355365Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Toz H, Atilla G, Hughes FJ, Belibasakis GN. Gingival crevicular fluid levels of RANKL and OPG in periodontal diseases: implications of their relative ratio. J Clin Periodontol. 2007 May;34(5):370-6. doi: 10.1111/j.1600-051X.2007.01061.x. Epub 2007 Mar 13.
- Results publication: PubMed 19656027Buduneli N, Buduneli E, Kutukculer N. Interleukin-17, RANKL, and osteoprotegerin levels in gingival crevicular fluid from smoking and non-smoking patients with chronic periodontitis during initial periodontal treatment. J Periodontol. 2009 Aug;80(8):1274-80. doi: 10.1902/jop.2009.090106.
- Results publication: PubMed 20192865Costa PP, Trevisan GL, Macedo GO, Palioto DB, Souza SL, Grisi MF, Novaes AB Jr, Taba M Jr. Salivary interleukin-6, matrix metalloproteinase-8, and osteoprotegerin in patients with periodontitis and diabetes. J Periodontol. 2010 Mar;81(3):384-91. doi: 10.1902/jop.2009.090510.
- Results publication: PubMed 21261673Bostanci N, Saygan B, Emingil G, Atilla G, Belibasakis GN. Effect of periodontal treatment on receptor activator of NF-kappaB ligand and osteoprotegerin levels and relative ratio in gingival crevicular fluid. J Clin Periodontol. 2011 May;38(5):428-33. doi: 10.1111/j.1600-051X.2011.01701.x. Epub 2011 Jan 24.
- Results publication: PubMed 20033478Dereka XE, Markopoulou CE, Fanourakis G, Tseleni-Balafouta S, Vrotsos IA. RANKL and OPG mRNA level after non-surgical periodontal treatment. Inflammation. 2010 Jun;33(3):200-6. doi: 10.1007/s10753-009-9174-7.
- Derived from this study: PubMed 25814780Hassan SH, El-Refai MI, Ghallab NA, Kasem RF, Shaker OG. Effect of periodontal surgery on osteoprotegerin levels in gingival crevicular fluid, saliva, and gingival tissues of chronic periodontitis patients. Dis Markers. 2015;2015:341259. doi: 10.1155/2015/341259. Epub 2015 Feb 28.
Related trials for Chronic Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
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.
Mahmoud ElRefai, M.D. study director
Professor of Oral Medicine and Periodontology , Faculty of oral and dental medicine Cairo Unv.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open flap debridement in people with Chronic Periodontitis, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 6 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 10 Jun 2014. 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 Egypt. 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 from baseline in Osteoprotegerin levels at 3 and 6 months (time frame: Baseline, 3 months and 6 months). 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 NCT02160613, which also lists 10 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 10 Jun 2014.