## Protocol Section
### Identification Module
**NCT ID:** NCT06438354

**Brief Title:** Non-surgical Step 3 Periodontal Treatment With/Without Adjunctive Protocol - Pilot RCT.

**Official Title:** Non-surgical Treatment of Residual Periodontal Pockets Using Sodium Hypochlorite/Amino Acid Gel and Cross-linked Hyaluronic Acid - a 9-month Randomized Controlled Clinical Trial.

#### Organization Study ID Info
**ID:** 64/2022
#### Organization
**Class:** OTHER
**Full Name:** University of Witten/Herdecke
### Status Module
#### Completion Date
**Date:** 2024-02-29

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-10-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-08-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Witten/Herdecke

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. Residual pockets ≥4mm with positive bleeding or such \>5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. Re-evaluations at 3 and 9 months controlled for clinical parameters such as Periodontal Probing Depth (PPD) (CAL), Clinical Attachment Level, Gingival Recession (GR), Bleeding on Probing (BOP). The hypothesis is, sites treated with adjunctive protocol show greater PPD reduction and greater CAL gain at 9-month evaluation.

### Conditions Module

**Conditions:**

- Periodontal Pocket

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 52

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Test arm, patients undergo subgingival instrumentation of residual active site together with an adjunctive treatment protocol.

**Intervention Names:**

- Biological: subgingival instrumentation plus Perisolv / hyaDent BG

**Label:** Group A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Control arm, patients undergo subgingival instrumentation of residual active site only.

**Intervention Names:**

- Procedure: subgingival instrumentation

**Label:** Group B

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A

**Description:** Group A: Perisolv is applied prior to subgingival instrumentation for disinfecting purpose, hyaDent BG seals the site for accelerated blood clot stabilisation and support of cell proliferation.

**Name:** subgingival instrumentation plus Perisolv / hyaDent BG

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Group B

**Description:** Group B: sites requiring re-treatment are subjected to subgingival scaling

**Name:** subgingival instrumentation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Greater amount of CAL gain in the test group A vs. control group B anticipated

**Measure:** Clinical Attachment Level

**Time Frame:** 9 month post-op

#### Secondary Outcomes

**Description:** Greater reduction in PPD for group A vs. Group B anticipated

**Measure:** Periodontal Probing Depth

**Time Frame:** 9 months post-op

**Description:** Similar change in the GR depth anticipated for both groups

**Measure:** Gingival Recession

**Time Frame:** 9 months post-op

**Description:** greater reduction in BOP anticipated for group A vs. group B patients.

**Measure:** Bleeding on Probing

**Time Frame:** 9 months post-op

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* systemically healthy individuals, smokers and non-smokers, HbA1c \<7.5%, compliant and adhering to systematic periodontal treatment protocol incl. SPT visits, patients willing to complete a 9-month post-op observation period

Exclusion Criteria:

* rheumatoid arthritis, HbA1c ≥7.5%, treatment of periodontitis within past 12 months, use of systemic antibiotics in past 6 months, pregnant and lactating individuals

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Munich

**Country:** Germany

**Facility:** Implantat Competence Centrum München

**Zip:** 80333

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23.

**PMID:** 37740107

**Citation:** Shirakata Y, Nakamura T, Setoguchi F, Imafuji T, Shinohara Y, Matsumura S, Iwata M, Noguchi K, Ramanauskaite E, Sculean A. Histological evaluation of nonsurgical periodontal treatment with and without the use of sodium hypochlorite / amino acids and cross-linked hyaluronic acid gels in dogs. Clin Oral Investig. 2024 Apr 27;28(5):281. doi: 10.1007/s00784-024-05674-7.

**PMID:** 38676852

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010518

- Term: Periodontitis

- 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: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13423

- Name: Periodontal Pocket

- Relevance: HIGH

- As Found: Periodontal Pocket

- ID: M13427

- Name: 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: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010514

- Term: Periodontal Pocket

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M15775

- Name: Sodium Hypochlorite

- Relevance: LOW

- As Found: Unknown

- ID: M44557

- Name: Eusol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
