PeriodontitisPhase 4SANSPETNCT02470611
Sodium Alendronate in Non Surgical Periodontal Therapy
A Phase 4 study testing Sodium alendronate in people with Periodontitis and Bone Resorption, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
In the past few years, studies have evaluated the effect of systemic use of sodium alendronate, especially in the treatment of structural bone defects caused by periodontal diseases. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Periodontitis, Bone Resorption
- What is being tested?
- Sodium alendronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2012to Nov 2014
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic periodontitis
- two contralateral teeth showing periodontal pocket depth ≥ 5mm, clinical attachment loss > 3mm, proximal vertical bone defects, no prosthetic device, without caries lesions, proximal dental contact and lack of premature occlusal contact
- systemically healthy volunteers
Who cannot join
- need for antibiotic or systemic/local antibiotic use in the previous 3 months
- periodontal treatment in the previous 6 months
- pregnancy or lactation
- immunological disorders or imune suppressive treatments
- diabetes
- smoking
Show all 10Show fewer
- orthodontic appliances or removable prosthesis
- osteoporosis
- known or suspected allergy to biphosphonates
- systemic use of biphosphonates
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dental clinic of pontifical catholic university
Belo Horizonte, Minas Gerais
About this study
Official title: Effects of 1% Sodium Alendronate in Non Surgical Periodontal Therapy on Clinical and Tomographical Parameters: a Randomized Placebo Controlled 6-month Clinical Trial
In the past few years, studies have evaluated the effect of systemic use of sodium alendronate, especially in the treatment of structural bone defects caused by periodontal diseases. This study evaluated the effects of non-surgical periodontal treatment associated with the topical application of 1% sodium alendronate on clinical and topographical parameters. Chronic periodontitis patients were recruited for the present study and were monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.
- Conditions
- Periodontitis, Bone Resorption
- Being tested
- Sodium alendronate, Placebo
- Medical subject headings
- Periodontitis, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium alendronateDrug
Also called biphosphonates
After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% sodium alendronate gel
PlaceboOther
After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% placebo gel
| Study group | Role | What they receive |
|---|---|---|
| Sodium Alendronate | Experimental | Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment Receives: Drug: Sodium alendronate |
| Placebo | Placebo comparator | Adjunctive use of placebo gel as part of periodontitis treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pocket depth
Reductions in pocket depth overtime
Measured: baseline and 3- and to 6-month evaluations
Changes in clinical attachment level
Gain in clinical attachment level overtime
Measured: baseline and 3- and to 6-month evaluations
Secondary outcomes (1)
Changes in bone defects
Reduction in bone defects by bone filling
Measured: Baseline 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 posted12 Jun 2015 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Pontifícia Universidade Católica de Minas Gerais
- Responsible party
- Principal investigator, Bernardo de Carvalho Dutra, Federal University of Minas Gerais
- Investigators
- Fernando O Costa, PhD, Study chair, Head of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470611
- Sponsor's protocol ID
- CAAE- 22493714.5.0000.5149
- Other IDs
- 22493714.5.0000.5149
- Acronym
- SANSPET
- Status last verified
- Jun 2015
- First submitted
- 2 Jun 2015
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 1% Sodium Alendronate in Non Surgical Periodontal Therapy on Clinical and Tomographical Parameters: a Randomized Placebo Controlled 6-month Clinical Trial
- ClinicalTrials.gov ID
- NCT02470611
- Acronym / sponsor ID
- SANSPET / CAAE- 22493714.5.0000.5149
- Conditions
- Periodontitis, Bone Resorption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Pontifícia Universidade Católica de Minas Gerais
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Jun 2015 (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.
In the past few years, studies have evaluated the effect of systemic use of sodium alendronate, especially in the treatment of structural bone defects caused by periodontal diseases. This study evaluated the effects of non-surgical periodontal treatment associated with the topical application of 1% sodium alendronate on clinical and topographical parameters. Chronic periodontitis patients were recruited for the present study and were monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Alendronate | Experimental | Drug: Sodium alendronateAdjunctive use of 1% sodium alendronate gel as part of periodontitis treatment |
| Placebo | Placebo comparator | Other: PlaceboAdjunctive use of placebo gel as part of periodontitis treatment |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- chronic periodontitis
- two contralateral teeth showing periodontal pocket depth ≥ 5mm, clinical attachment loss > 3mm, proximal vertical bone defects, no prosthetic device, without caries lesions, proximal dental contact and lack of premature occlusal contact
- systemically healthy volunteers
Key exclusion criteria (10 listed)
- need for antibiotic or systemic/local antibiotic use in the previous 3 months
- periodontal treatment in the previous 6 months
- pregnancy or lactation
- immunological disorders or imune suppressive treatments
- diabetes
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 |
|---|---|---|
| Sodium alendronateAlso: biphosphonatesAfter manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% sodium alendronate gel | Drug | Sodium Alendronate |
| PlaceboAfter manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% placebo gel | Other | Placebo |
Primary outcome
Changes in pocket depth
Time frame: baseline and 3- and to 6-month evaluations
Reductions in pocket depth overtime
Changes in clinical attachment level
Time frame: baseline and 3- and to 6-month evaluations
Gain in clinical attachment level overtime
1 secondary outcome
Changes in bone defects
Time frame: Baseline 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 12 Jun 2015.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Fernando O Costa, PhD study chair
Head of Periodontology
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 Sodium alendronate in people with Periodontitis and Bone Resorption, run by Federal University of Minas Gerais at 1 site in Brazil.
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 10 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 12 Jun 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 Brazil. 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. 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 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?
Changes in pocket depth (time frame: baseline and 3- and to 6-month evaluations). 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 12 Jun 2015.