Clinical split-mouth study: Comparison of the Clean-and-Seal concept (Perisolv® & Hyadent BG®) in combination with anti-infective therapy (AIT) versus anti-infective therapy (AIT) alone on the modification of clinical parameters in patients with periodontitis.

Clinical split-mouth study: Comparison of the Clean-and-Seal concept (Perisolv® & Hyadent BG®) in combination with anti-infective therapy (AIT) versus anti-infective therapy (AIT) alone on the modification of clinical parameters in patients with periodontitis. - CLEAN-ATTACH

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039020

Enrollment

Registered

2026-01-23

Start date

2026-03-16

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K05.3

Interventions

Group 1: Intervention Group 1 (Test group – Split-mouth) Each study participant will receive both the test and control treatments: in one jaw, periodontal therapy will be performed as a combination o

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria: • Untreated patients with severe/advanced periodontitis (Stage III/IV) with slow/moderate progression (Grade A/B) • Only individuals capable of giving consent, aged = 18 years • Presence of at least one probing depth (PD) = 6 mm per jaw • Single-rooted teeth or multi-rooted teeth without furcation involvement

Exclusion criteria

Exclusion criteria: Exclusion Criteria: • Patients with systemic diseases, particularly: o Use of bisphosphonates o Ongoing or previous chemotherapy o Ongoing or previous radiotherapy o Infectious diseases such as HIV or Hepatitis A, B, or C • Pregnant or breastfeeding women • Smokers of more than 10 cigarettes per day • Periodontal treatment within the last 2 years • Long-term antibiotic or anti-inflammatory therapy within 6 months prior to periodontal treatment • Furcation involvement • Acute periodontal or endodontic abscesses • Wisdom teeth (third molars) are not included in the treatment

Design outcomes

Primary

Measure	Time frame
The primary objective of this split-mouth study is to assess and compare the clinical effects of two periodontal treatment approaches in patients with periodontitis: the application of anti-infective therapy alone versus the combination of anti-infective therapy and the “Clean and Seal” concept (Perisolv® and Hyadent BG®). The main focus of the investigation is the change in clinical attachment level (CAL) as the primary outcome. Secondary outcomes include probing pocket depth (PPD), the extent of recession (REC), bleeding on probing (BOP), and overall improvement of the periodontal condition. Data will be collected at 3, 6, and 12 months. The treatment study is conducted in a split-mouth design, where each patient receives both treatments within the same jaw. One jaw is treated with anti-infective therapy alone, while the other jaw receives anti-infective therapy combined with Perisolv® and Hyadent BG® (Clean and Seal). The following hypothesis is proposed: The combined application of Perisolv® and Hyadent BG® (Clean and Seal) together with anti-infective therapy leads to a significant improvement in clinical parameters, especially clinical attachment level (CAL), probing pocket depth (PPD), and bleeding on probing (BOP), compared to anti-infective therapy alone. Randomization: 1:1 computer-generated, split-mouth allocation (maxilla vs. mandible), table for 22 participants prepared prior to study initiation. • Improvement of clinical attachment (CAL gain) • Improvement of recession (REC reduction) • Reduction of probing pocket depths (PPD reduction, i.e., ST) • Reduction of bleeding on probing (BOP reduction)	—

Measure

Time frame

The primary objective of this split-mouth study is to assess and compare the clinical effects of two periodontal treatment approaches in patients with periodontitis: the application of anti-infective therapy alone versus the combination of anti-infective therapy and the “Clean and Seal” concept (Perisolv® and Hyadent BG®). The main focus of the investigation is the change in clinical attachment level (CAL) as the primary outcome. Secondary outcomes include probing pocket depth (PPD), the extent of recession (REC), bleeding on probing (BOP), and overall improvement of the periodontal condition. Data will be collected at 3, 6, and 12 months. The treatment study is conducted in a split-mouth design, where each patient receives both treatments within the same jaw. One jaw is treated with anti-infective therapy alone, while the other jaw receives anti-infective therapy combined with Perisolv® and Hyadent BG® (Clean and Seal). The following hypothesis is proposed: The combined application of Perisolv® and Hyadent BG® (Clean and Seal) together with anti-infective therapy leads to a significant improvement in clinical parameters, especially clinical attachment level (CAL), probing pocket depth (PPD), and bleeding on probing (BOP), compared to anti-infective therapy alone. Randomization: 1:1 computer-generated, split-mouth allocation (maxilla vs. mandible), table for 22 participants prepared prior to study initiation. • Improvement of clinical attachment (CAL gain) • Improvement of recession (REC reduction) • Reduction of probing pocket depths (PPD reduction, i.e., ST) • Reduction of bleeding on probing (BOP reduction)

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Countries

Germany

Contacts

Public ContactPetra Gierthmühlen

Universitätsklinikum Düsseldorf Poliklink für Zahnerhaltung, Parodontologie und Endodontologie

Petra.Gierthmuehlen@med.uni-duesseldorf.de+49(0)2118818142

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026