## Protocol Section
### Identification Module
**NCT ID:** NCT02779179

**Acronym:** ESPERA

**Brief Title:** Therapeutic Management of Periodontitis and Clinical Manifestations of Rheumatoid Arthritis

**Official Title:** Efficacy of Therapeutic Management of Periodontitis on the Clinical Manifestations of Rheumatoid Arthritis: the Randomized, Controlled ESPERA Trial.

#### Organization Study ID Info
**ID:** 10 046 08
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Toulouse
#### Secondary ID Infos
**Domain:** National Agency of Drug Safety and Health Products
**ID:** 2010-A01193-36
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2016-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-12-03

**Type:** ACTUAL

**Last Update Submit Date:** 2018-11-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-11

**Type:** ACTUAL

#### Start Date
**Date:** 2010-11

**Type:** ACTUAL

**Status Verified Date:** 2018-11

#### Study First Post Date
**Date:** 2016-05-20
**Type:** ESTIMATED
**Study First Submit Date:** 2015-07-10
**Study First Submit QC Date:** 2016-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Toulouse

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Although RA pathomechanisms remains incompletely understood, periodontitis and RA share pathogenic features : genetic and environmental influences, chronic inflammatory disease, immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical factors (conjunctive and hard tissues destruction). Several hypothesis can be evocated : Gram negative bacterial systemic spreading, inflammatory transmitter substance systemic spreading (IL1, IL6, IL17, PGE2), systemic spreading of bacterial degradation products (LPS for example).

Currently Porphyromonas gingivalis (PG) might be a susceptibility factor to RA because PG has an enzyme, the peptidylarginine deiminase leading to auto antibodies creation and RA increasing. As periodontitis, RA is chronic disease with a cyclic increase evolution, needing a complex pluridisciplinary treatment approach. Recent studies have reported an increased prevalence of RA patients with periodontal disease. Others studies show that periodontal treatment induces a significant decrease of the sedimentation rate and of the DAS28. Periodontitis is suspected to be an independent, aggravating factor in patients with RA (given the definition from NIH : an aggravating factor is something that makes a condition worse). So periodontal treatment cannot be considered as a RA treatment per se. But it is hypothesised that treating periodontitis in RA patients showing signs of periodontitis could result in improvement in RA disease activity. To date the role of periodontitis as an aggravating factor in these patients remains unclear, and only RCT designs can reasonably be used to test this causal hypothesis. There still remains some RA patients who have persistent symptoms and frequent exacerbations despite specialist care and continuous treatment, so results of treating aggravating factors are needed. As the majority of patients will benefit from a systematic evaluation and treatment of aggravating factors, the periodontal treatment strategy need to be tested.

The aim of this randomised controlled trial is to assess the effectiveness of periodontal treatment for rheumatoid arthritis patients.

To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis. The hypothesis is that periodontal treatment reduce the severity of rheumatoid arthritis.

### Conditions Module

**Conditions:**

- Periodontitis

- Rheumatoid Arthritis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 22

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Periodontal treatment

**Label:** Immediate Periodontal treatment group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: Periodontal treatment

**Label:** Delayed Periodontal treatment Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Delayed Periodontal treatment Group

- Immediate Periodontal treatment group

**Description:** * Mechanical debridement (scaling, root planning, subgingival curettage)
* Antimicrobial therapy (systematically administered: amoxicillin or clindamycin).
* Antiseptic mouthrinses, gel or dentifrice
* Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus)

**Name:** Periodontal treatment

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Evaluation of parodontitis therapeutic care as assessed by variation in DAS28 score

**Time Frame:** Day 15 and day 90

#### Secondary Outcomes

**Measure:** Evaluation of parodontitis therapeutic care as assessed by variation in ACR 20 score

**Time Frame:** Day 15 and day 90

**Measure:** Evaluation of parodontitis therapeutic care as assessed by variation in HAQ score

**Time Frame:** Day 15 and day 90

**Measure:** Evaluation of parodontitis therapeutic care as assessed by variation in GOHAI score

**Time Frame:** Day 15 and day 90

### Eligibility Module

**Eligibility Criteria:** INCLUSION CRITERIA:

* rheumatoid arthritis diagnosed for at least one year
* DAS28 score between 3.2 and 5.1
* no change to medication, dosage or formulation in RA treatment during the 3 months preceding the screening visit
* subject available for all study visits over three months in the Dental Care Departments (V1 to V4)
* subjects with at least six natural teeth with root
* subject with periodontitis, defined by the presence of one site with periodontal probing depth ≥ 4 mm and clinical attachment level ≥ 3 mm on at least 4 teeth.
* subject has given his informed consent: 1 week cooling-off period

EXCLUSION CRITERIA:

* subject will not qualify for enrolment if he presents at least one of the following: acute oral infection, acute oral pain (including pulpitis), suspicious oral mucosal lesion, severe oral inflammation unrelated to periodontal conditions, or need for immediate tooth extractions
* have a planned hospitalization within 4 months after the screening visit
* subject suffering from one or more known infectious diseases (HIV, hepatitis, infectious mononucleosis),
* subject suffering from known clinically significant renal disease (creatinine clearance \<60 ml/min), or liver disease,
* unbalanced diabetes
* have a known risk of endocarditis,
* have a permanent pacemaker,
* subject taking antithrombotic treatment,
* subject having severe difficulties in understanding written and spoken French
* for females: are pregnant or intending to become pregnant, or lactating
* subject suffering from a chronic disorder that requires chronic or intermittent use of antibiotics,
* subject having known hypersensitivity to chlorhexidine gluconate
* are participating in another intervention study
* have known contraindications to both amoxicillin and clindamycin
* have known contraindications to dental local anesthetic.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bordeaux

**Country:** France

**Facility:** CHU de Bordeaux

**Zip:** 33000

**Location 2:**

**City:** Toulouse

**Country:** France

**Facility:** Pôle Odontologie Hôpital Purpan - Pavillon Rayer

**Zip:** 31059

#### Overall Officials

**Official 1:**

**Affiliation:** Faculté de chirurgie dentaire - Toulouse

**Name:** Paul MONSARRAT, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M4480

- Name: Arthritis, Rheumatoid

- Relevance: HIGH

- As Found: Rheumatoid Arthritis

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

- ID: D000001172

- Term: Arthritis, Rheumatoid

- ID: D000010518

- Term: Periodontitis

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3995

- Name: Amoxicillin

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6214

- Name: Clindamycin

- Relevance: LOW

- As Found: Unknown

- ID: M220697

- Name: Clindamycin palmitate

- Relevance: LOW

- As Found: Unknown

- ID: M231711

- Name: Clindamycin phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4215

- Name: Anti-Infective Agents, Local

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
