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Intrabony Periodontal DefectPhase 4NCT03769402

The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile

A Phase 4 study testing Citric acid in people with Intrabony Periodontal Defect, run by Ain Shams University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the effect of citric acid on bone surface of infrabony defects when used for 30 seconds at ph 1 and 50% concentration before the application of bovine derived xenograft to fill the defect, Bone Morphogenic protein 2 (BMP-2) marker was evaluated in 5 different days during the first month after… Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Intrabony Periodontal Defect
What is being tested?
Citric acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 1 Nov 2018
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 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Both genders aged between 32-60 years.
  • Selected patient with a single site of:
  • Two walled or three walled infra-bony defect.
  • The bone defect should be at least 3 mm in depth from the crest of the alveolar bone to the base of the defect.
  • Pocket depth of more than or equal to 5 mm.
  • Clinical attachment loss equal or more than 3mm
  • Patients ready to comply with oral hygiene measures.

Who cannot join

  • Any systemic disease that contra-indicates periodontal surgery or may affect healing.
  • Smokers
  • Pregnant females
  • Drug abusers

About this study

Official title: The Influence of Citric Acid Bone Surface Etching and Bone Substitute Intra-osseous Defect Fill on Crevicular Fluid BMP-2 Release Profile (Randomized Clinical Trial)

This study evaluates the effect of citric acid on bone surface of infrabony defects when used for 30 seconds at ph 1 and 50% concentration before the application of bovine derived xenograft to fill the defect, Bone Morphogenic protein 2 (BMP-2) marker was evaluated in 5 different days during the first month after surgery and clinical and radiographic parameters were reassessed after 6 months

Read the detailed description

Citric acid have been widely used to treat root surfaces of periodontally affected teeth in order to render it biologically suitable for fibroblast reattachment. however, systematic reviews showed no clinical significance when it was used as a root surface conditioner. Recently it was found in experimental studies that when citric acid was used on bone surface for a brief period, it increased bone formation and improved consolidation of grafted bone to bone bed. In this study infrabony defects were treated with citric acid PH 1 and 50% concentration for 30 seconds before washing it off and then application of bovine derived xenograft was done to fill the defect. BMP-2 marker was evaluated at days 1,3,7,14 and 30 by taking a sample using perio-paper from the gingival crevicular fluid (GCF) and clinical and radiographic parameters were taken after 6 months of follow-up

Being tested
Citric acid, Control Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Citric acidDrug

    Citric acid ph1, 50% concentration solution

  • Control TestDrug

    Also called Control

    Control group, xenograft was used to fill infrabony defects without treating bone surface

Study groups in NCT03769402
Study groupRoleWhat they receive
Citric acidActive comparatorCitric acid PH1 and concentration 50% was used for 30 seconds on bone surface before washing it off and filling the defect with xenograft
Receives: Drug: Citric acid
ControlPlacebo comparatorControl test
Receives: Drug: Control Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone Morphogenic protein 2

    The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)

    Measured: 1 day

  2. Bone Morphogenic protein 2

    The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)

    Measured: 3 days

  3. Bone Morphogenic protein 2

    The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)

    Measured: 7 days

  4. Bone Morphogenic protein 2

    The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)

    Measured: 14 days

  5. Bone Morphogenic protein 2

    The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)

    Measured: 30 days

Secondary outcomes (5)

  1. Gingival Index

    Estimation of the degree of gingival inflammation was done according to Loe where scores were given between 0-3 (0=no inflammation and 3=severe inflammation)

    Measured: 6 months

  2. Plaque index

    Estimation of the amount of dental plaque according to Silness \& Loe where scores were given between 0-3 (0=no plaque and 3=presence of abundant plaque)

    Measured: 6 months

  3. Probing depth

    Estimation was done by measuring the depth from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe

    Measured: 6 months

  4. Clinical attachment level

    Estimation was done by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC-15 periodontal probe

    Measured: 6 months

  5. Radiographic bone fill

    Estimation was done by taking a linear measurement using RVG system from the baseline defect till the alveolar bone crest

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2018
  2. Study start1 Jan 2016
  3. Primary completion1 May 2018
  4. Study completion1 Nov 2018

Resources

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
Model description
Randomized clinical trial
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03769402
Sponsor's protocol ID
52-376
Status last verified
Dec 2018
First submitted
6 Dec 2018
Last updated
7 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Citric acid in people with Intrabony Periodontal Defect, run by Ain Shams University.

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 7 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 7 Dec 2018. 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 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?

Bone Morphogenic protein 2 (time frame: 1 day). 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 NCT03769402.

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 7 Dec 2018.

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