CompletedPhase 4

Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis

40 participantsStarted 2016-01

Plain-language summary

Modified perforated membrane (MPM) is considered as a modality that could enable participation of periosteal cells and gingival stem cells which could improve the outcomes of guided tissue regeneration more than the use of the traditional occlusive membrane (OM). Simvastatin (SMV) modulates bone formation by increasing the expression of bone morphogenetic protein 2 and angiogenesis. Ethylenediaminetetraacitic acid (EDTA) found to be effective as low ph etchant for smear layer removal and exposing root surface collagen. The investigators compared the clinical and radiographic outcome of SMV gel combined with MPM to SMV gel combined with OM with and without an associated EDTA gel root surface etching for improving bone regeneration in intrabony defects in chronic periodontitis patients. Moreover, evaluation of SMV gingival crevicular fluid (GCF) levels availability for 30 days in cases with and without EDTA root surface etching was performed.

Who can participate

Age range

30 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Probing depth \> 5 mm.
. Clinical attachment loss \>4 mm.
. Standardized radiographic evidence of interproximal intrabony defect using periapical radiograph.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Probing pocket depth

Timeframe: Baseline to 9 months

Clinical attachment level

Timeframe: Baseline to 9 months

Plaque index

Timeframe: Baseline to 9 months

Gingival index

Timeframe: Baseline to 9 months

Linear measurements

Timeframe: Baseline to 9 months

Radiodensitometric measurements

Timeframe: Baseline to 9 months

Trial details

NCT IDNCT03419429

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06

View on ClinicalTrials.gov More Chronic Periodontitis trials

Plain-language summary

Who can participate

Age range

30 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Probing depth \> 5 mm.
. Clinical attachment loss \>4 mm.
. Standardized radiographic evidence of interproximal intrabony defect using periapical radiograph.

What they're measuring

Probing pocket depth

Timeframe: Baseline to 9 months

Clinical attachment level

Timeframe: Baseline to 9 months

Plaque index

Timeframe: Baseline to 9 months

Gingival index

Timeframe: Baseline to 9 months

Linear measurements

Timeframe: Baseline to 9 months

Radiodensitometric measurements

Timeframe: Baseline to 9 months