Chronic PeriodontitisPhase 2NCT02168543
1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers
A Phase 2 study testing Alendronate in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore.
Trial summary
Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases new bone formation in chronic periodontitis patients Till date no study has reported the effect of local delivery of ALN in chronic periodontitis patients among smokers. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Alendronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Apr 2011
- Phase
- Phase 2
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy subjects with probing depth (PD) ≥ 5 mm or periodontal attachment level (PAL) ≥ 4 to 6 mm and a radiographical vertical bone loss ≥ 3 mm
- No history of periodontal therapy in preceding last 6 months
- No use of antibiotics in the preceding 6 months
Who cannot join
- Subjects with known systemic disease
- Known or suspected allergy to the ALN/bisphosphonate group
- Those on systemic ALN/bisphosphonate therapy
- Subjects with aggressive periodontitis,
- Use of smokeless tobacco in any form,
- Alcoholics
- Immunocompromised subjects
- Pregnant or lactating females
About this study
Official title: Clinical Efficacy of Subgingivally Delivered 1% Alendronate in the Treatment of Smokers With Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial.
- Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases new bone formation in chronic periodontitis patients
- Till date no study has reported the effect of local delivery of ALN in chronic periodontitis patients among smokers. Hence the aim of this study is to investigate the clinical and radiographic effects of locally delivered ALN as an adjunct to the non surgical treatment in smoker chronic periodontitis patients.
- Conditions
- Chronic Periodontitis
- Being tested
- Alendronate, Placebo
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Alendronate | Experimental | 1% Alendronate gel once in periodontal pocket (Gums) Receives: Drug: Alendronate |
| Placebo | Placebo comparator | Placebo gel once in periodontal pocket (Gums) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline plaque scores at 2 month and 6 month
Plaque scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Measured: At baseline, 2nd month and 6th month
Change from baseline gingival scores at 2 month and 6 month
Gingival scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Measured: At baseline, 2nd month and 6th month
Secondary outcomes (3)
Change from baseline Probing depth at 2 month and 6 month
Probing depth assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Measured: At baseline, 2nd month and 6th month
Change from baseline Periodontal attachment level at 2 month and 6 month
Periodontal attachment level assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Measured: At baseline, 2nd month and 6th month
Change from baseline intrabony defect depth at 6 month
intrabony defect depth assessed at baseline and 6 months for Alendronate and placebo group
Measured: At baseline and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMar 2009
- Primary completionJan 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Dental College and Research Institute, Bangalore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anuj Sharma, Government Dental College and Research Institute, Bangalore
- Investigators
- Dr. Anuj Sharma, BDS, MDS, Principal investigator, RIMS, Ranchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168543
- Sponsor's protocol ID
- GDCRI-09-03
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Subgingivally Delivered 1% Alendronate in the Treatment of Smokers With Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02168543
- Acronym / sponsor ID
- GDCRI-09-03
- Conditions
- Chronic Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 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.
- Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases new bone formation in chronic periodontitis patients
- Till date no study has reported the effect of local delivery of ALN in chronic periodontitis patients among smokers. Hence the aim of this study is to investigate the clinical and radiographic effects of locally delivered ALN as an adjunct to the non surgical treatment in smoker chronic periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alendronate | Experimental | Drug: Alendronate1% Alendronate gel once in periodontal pocket (Gums) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo gel once in periodontal pocket (Gums) |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy subjects with probing depth (PD) ≥ 5 mm or periodontal attachment level (PAL) ≥ 4 to 6 mm and a radiographical vertical bone loss ≥ 3 mm
- No history of periodontal therapy in preceding last 6 months
- No use of antibiotics in the preceding 6 months
Key exclusion criteria (8 listed)
- Subjects with known systemic disease
- Known or suspected allergy to the ALN/bisphosphonate group
- Those on systemic ALN/bisphosphonate therapy
- Subjects with aggressive periodontitis,
- Use of smokeless tobacco in any form,
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 |
|---|---|---|
| Alendronate | Drug | Alendronate |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline plaque scores at 2 month and 6 month
Time frame: At baseline, 2nd month and 6th month
Plaque scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Change from baseline gingival scores at 2 month and 6 month
Time frame: At baseline, 2nd month and 6th month
Gingival scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
3 secondary outcomes
Change from baseline Probing depth at 2 month and 6 month
Time frame: At baseline, 2nd month and 6th month
Change from baseline Periodontal attachment level at 2 month and 6 month
Time frame: At baseline, 2nd month and 6th month
Change from baseline intrabony defect depth at 6 month
Time frame: At baseline and 6th month
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 20 Jun 2014.
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.
Dr. Anuj Sharma, BDS, MDS principal investigator
RIMS, Ranchi
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alendronate in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore.
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 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline plaque scores at 2 month and 6 month (time frame: At baseline, 2nd month and 6th month). 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?
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 20 Jun 2014.