Evidence map›Paper›PMID 31327083›Full record

Trial reportClinical oral investigations2020

Novel 20% doxycycline-loaded PLGA nanospheres as adjunctive therapy in chronic periodontitis in type-2 diabetics: randomized clinical, immune and microbiological trial.

Giovana Lecio, Fernanda Vieira Ribeiro, Suzana Peres Pimentel, Aurélio Amorin Reis, Rafaela Videira Clima da Silva, Francisco Nociti-Jr, Lucas Moura, Eliane Duek, Marcio Casati, Renato Corrêa Viana Casarin

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical oral investigations, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  14. Porous PLGA microspheres loaded with PTHJournal of orthopaedic translation · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Giovana LecioPaulista University, São Paulo, Brazil.
Fernanda Vieira RibeiroPaulista University, São Paulo, Brazil.
Suzana Peres PimentelPaulista University, São Paulo, Brazil.
Aurélio Amorin ReisPiracicaba Dental School, State University of Campinas, Piracicaba, Brazil.
Rafaela Videira Clima da SilvaPiracicaba Dental School, State University of Campinas, Piracicaba, Brazil.
Francisco Nociti-JrPiracicaba Dental School, State University of Campinas, Piracicaba, Brazil.
Lucas MouraPiracicaba Dental School, State University of Campinas, Piracicaba, Brazil.
Eliane DuekSchool of Biological Sciences, Pontifical Catholic University of São Paulo, Sorocaba, Brazil.
Marcio CasatiPaulista University, São Paulo, Brazil.
Renato Corrêa Viana CasarinPiracicaba Dental School, State University of Campinas, Piracicaba, Brazil. casarinrcv@yahoo.com.br.ORCID http://orcid.org/0000-0003-1743-5855

Funding

Fundação de Amparo à Pesquisa do Estado de São Paulo 2012/22492-0Fundação de Amparo à Pesquisa do Estado de São Paulo 2012/50877-3
6 · The paper itself

Abstract

objectiveThis study evaluated the clinical, microbiological, and immunological results of poly lactic-co-glycolic acid (PLGA) nanospheres containing 20% doxycycline (DOXY) in the treatment of type-2 diabetic patients (DM-2) with chronic periodontitis (CP). MATERIAL AND

methodsA parallel, double-blind, randomized, placebo-controlled clinical trial was conducted in DM-2 presenting severe and generalized CP. All patients received one-stage full-mouth ultrasonic debridement (FMUD) and they were randomly divided into two groups: PLAC (n = 20)-local application of placebo PLGA nanospheres, and DOXY (n = 20)-local application of doxycycline-loaded nanospheres; both in six non-contiguous sites. Clinical, metabolic (fasting plasma glucose level-FPG and glycated hemoglobin-HbA1c), cytokine pattern (multiplexed bead immunoassay) and microbiological assessments were performed at baseline, and 1, 3, and 6 months after treatment.

resultsBoth groups showed clinical improvement in all parameters after treatment (p < 0.05). Deep pockets showed improvements in bleeding on probing-BoP (3 and 6 months), PD (at 3 months), and CAL gain (at 1 and 3 months) favoring DOXY (p < 0.05). The percentage of sites presenting PD reduction and CAL gain ≥ 2 mm was higher in DOXY at 3 months (p < 0.05). DOXY group exhibited a significant increase in the levels of anti-inflammatory interleukin (IL)-10 and a reduction in IL-8, IFN-y, IL-6, and IL-17 (p < 0.05), significant reduction in periodontal pathogens (p < 0.05), and a lower mean percentage of HbA1C at 3 months (p < 0.05).

conclusionDOXY nanospheres may be considered a potential adjunct to mechanical debridement in the therapy of periodontitis in DM-2, offering additional benefits in deep pockets, improving the cytokine profile, and reducing periodontal pathogen levels. CLINICAL RELEVANCE: The use of locally applied doxycycline nanospheres may represent an adjunctive therapeutic approach in the treatment of periodontal disease in type-2 diabetic patients, achieving additional benefits in the local modulation of cytokines, microbial reduction, and clinical parameters, especially in deep pockets.

Indexed as

NanospheresAdultAgedAnti-Bacterial AgentsChronic PeriodontitisCytokinesDental ScalingDiabetes Mellitus, Type 2Double-Blind MethodDoxycyclineFemaleHumansMaleMiddle AgedPolylactic Acid-Polyglycolic Acid CopolymerAnti-Bacterial AgentsCytokinesDoxycyclinePolylactic Acid-Polyglycolic Acid CopolymerChronic periodontitisDelivery vehicleDiabetes mellitus type 2DoxycyclineNanospheres

Identifiers

PMID31327083

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.