NCT05543434

Brief Summary

sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 14, 2022

Last Update Submit

September 16, 2022

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • Clinical attachment level gain

    Clinical attachment gain by using UNC15 Periodontal probe/ numerical data

    3 months

Secondary Outcomes (4)

  • Pocket depth reduction

    3 moths

  • Bleeding on probing

    3 months

  • Gingival Recession

    3 months

  • Radiographic Evaluation

    3 months

Study Arms (2)

hyaluronic acid

EXPERIMENTAL

Application of crosslinked HA gel in pockets after subgingival debridement immediately and one week after.

Drug: Hyaluronic acid

scaling and root planing

ACTIVE COMPARATOR

scaling and root planing using ultrasonic scaler and hand instruments.

Drug: Hyaluronic acid

Interventions

Hyaluronic acidDRUG

anti-inflammatory, anti-edematous, osseoinductive.

Also known as: Gingigel /Germany
hyaluronic acidscaling and root planing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 years.
  • Patient with controlled diabetic type 2 (HgA1C \<7) (Mori et al., 2021).
  • Periodontitis stage II.
  • Periodontitis grade B.
  • Pocket depth \> 4 mm.
  • Smoking ≤ 10 cigarettes/day.
  • Cooperative patients able and accept to come for follow up appointments

You may not qualify if:

  • The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
  • Having surgical therapy or undergoing orthodontic treatment.
  • Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
  • Pregnant and lactation females.
  • Smoking ˃ 10 cigarettes/day.
  • Patients with poor oral hygiene.
  • Any known allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry Cairo university

Cairo, 12311, Egypt

RECRUITING

Related Publications (1)

  • Al-Abbadi R, Shemais N, Nawwar A, Fawzy El-Sayed KM. Non-surgical periodontal therapy with and without hyaluronic acid gel in type 2 diabetic stage-II periodontitis patients: a randomized clinical trial. BMC Oral Health. 2025 Jul 15;25(1):1166. doi: 10.1186/s12903-025-06485-2.

    PMID: 40665270DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Reem M Alabbadi, BDS

    master student

    PRINCIPAL INVESTIGATOR

  • Nesma M Shemais, PHD

    Lecturer of Oral Medicine and Periodontology- faculty of dentistry/Cairo University

    STUDY DIRECTOR

  • Karim F Elsayed, professor

    Associate Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University

    STUDY CHAIR

Central Study Contacts

Reem M Alabbadi, BDS

CONTACT

00201551563633reem.alabbadi@dentistry.cu.edu.eg

Nesma M Shemais, PHD

CONTACT

00201005615697nesma.shemais@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 16, 2022

Study Start

December 1, 2022

Primary Completion

March 1, 2023

Study Completion

December 1, 2023

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

EG(1)