## Protocol Section
### Identification Module
**NCT ID:** NCT02407379

**Acronym:** PAPD

**Brief Title:** Diode Laser and SRP in Chronic Periodontitis

**Official Title:** Photoablative-photodynamic (PAPD) Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis

#### Organization Study ID Info
**ID:** OLTC014
#### Organization
**Class:** OTHER
**Full Name:** Odontostomatologic Laser Therapy Center, Florence, Italy
### Status Module
#### Completion Date
**Date:** 2018-08-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-08-31

**Type:** ACTUAL

**Last Update Submit Date:** 2018-08-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-10

**Type:** ACTUAL

#### Start Date
**Date:** 2015-10

**Status Verified Date:** 2018-08

#### Study First Post Date
**Date:** 2015-04-03
**Type:** ESTIMATED
**Study First Submit Date:** 2014-07-09
**Study First Submit QC Date:** 2015-04-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Odontostomatologic Laser Therapy Center, Florence, Italy

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to compare the efficacy of photoablative and photodynamic diode laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of periodontitis.

**Detailed Description:** The present study is a randomized, blinded, controlled clinical trial, which used a split-mouth design. All patients were informed individually about the nature of the proposed treatment, and informed consent forms were signed. Twenty-four patients were studied. Maxillary left or right quadrants were randomly assigned to PAPD laser treatment or sham-treatment and SRP. PAPD consisted of: i) photoablative gingival epithelium with diode laser (λ 810 nm, 1 W); ii) photodynamic treatments (4-10 weekly) with diode laser (λ 635 nm, 100 mW) and 0.3% methylene blue as photoactive antiseptic, performed after SRP. Sham-treatment was similar but with switched off laser.

Efficacy evaluations, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) was performed at baseline ,1year, and year 3 using a conventional manual periodontal probe. Polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples at baseline, 6 month and 1, 3, 5 years.

### Conditions Module

**Conditions:**

- Periodontitis

**Keywords:**

- Laser

- periodontitis

- scaling root planing

- bacteria

- PMN

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 24

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP

**Intervention Names:**

- Procedure: PAPD+SRP

**Label:** PAPD+SRP Quadrant

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP

**Intervention Names:**

- Procedure: Sham-laser +SRP

**Label:** Sham-laser + SRP

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PAPD+SRP Quadrant

**Description:** Photoablation of the gingival epithelium was performed with at 810 nm diode laser (1 W output power, continuous wave mode, 66.7 J/cm2, a 0.6 mm optical fiber). SRP was performed using curettes. The periodontal tissues and the dental root were rinsed with the photosensitizer agent methylene blue (0.3% w/v in water). After 5 min., the treated areas were irradiated with at 635 nm diode laser (100 mW output power, continuous wave mode, 0.6 mm optic fiber). The photodynamic treatment was repeated once weekly until normalization of the cytodiagnostic parameters (range: 4-10 applications).

**Name:** PAPD+SRP

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Sham-laser + SRP

**Description:** Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing

**Name:** Sham-laser +SRP

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Change in probing pocket depth

**Measure:** PD

**Time Frame:** baseline, 1 year

#### Secondary Outcomes

**Description:** Change in mean attachment level

**Measure:** CAL

**Time Frame:** baseline, 1 year

**Description:** Change in mean bleeding on probing

**Measure:** BoP

**Time Frame:** baseline, 1 year

**Description:** Change in mean additional disease markers, namely polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples.

**Measure:** PMN, DEC, bacteria

**Time Frame:** baseline, 1 year

**Description:** Individual evaluation of pain/discomfort assessed by a visual analogue score interview

**Measure:** Patient-reported outcomes

**Time Frame:** baseline, 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Periodontitis:Presence of at least two teeth with at least one site with pocket probing depth (PD) ranging from 4 to 10 mm in each upper maxillary quadrant and with bleeding on probing (BOP)
2. A minimum of five natural teeth in each studied quadrant.

Exclusion Criteria:

1. History of systemic diseases (diabetes mellitus, cancer, HIV, metabolic and endocrine diseases)
2. Pregnancy or lactation
3. Chronic high-dose steroid use
4. Previous or current radiation or immunosuppressive therapies
5. Ongoing orthodontic treatments
6. Extensive carious lesions
7. Recurrent antibiotic medications during the 6 months preceding the study
8. Class III tooth mobility
9. Heavy contamination by spirochetes and fungal pathogens on tongue and oral mucosa

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Florence

**Country:** Italy

**Facility:** Odontostomatologic laser therapy center

**Zip:** 50143

#### Overall Officials

**Official 1:**

**Affiliation:** Odontostomatologic laser therapy center

**Name:** Marco Giannelli

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Giannelli M, Materassi F, Fossi T, Lorenzini L, Bani D. Treatment of severe periodontitis with a laser and light-emitting diode (LED) procedure adjunctive to scaling and root planing: a double-blind, randomized, single-center, split-mouth clinical trial investigating its efficacy and patient-reported outcomes at 1 year. Lasers Med Sci. 2018 Jul;33(5):991-1002. doi: 10.1007/s10103-018-2441-9. Epub 2018 Jan 18.

**PMID:** 29349511

## Derived Section

### Condition Browse Module - Ancestors

- 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: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M28044

- Name: Chronic Periodontitis

- 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

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M11726

- Name: Methylene Blue

- Relevance: LOW

- As Found: Unknown

- ID: M19608

- Name: Photosensitizing Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
