Trials Sponsors Conditions Drugs Pricing

Conditions

Periodontal Disease, AVDC Stage 3

Keywords

Stage III periodontitisMelatonin gelXenograft

Outcome Measures

Primary Outcomes (1)

- Radiographic evaluation of the changes in the intrabony defect
The amount of bone gain in millimeters in follow up radiograph compared to preoperative radiograph
6 months

Secondary Outcomes (2)

Clinical evaluation of the changes in periodontal parameters
Baseline and 6 months
Evaluation of surgical wound healing
1 and 2 weeks after surgery.

Study Arms (2)

Melatonin gel with Xenograft group

EXPERIMENTAL

Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft mixed with 5% melatonin gel.

Drug: Melatonin gel mixed with xenograft

Xenograft Only group

ACTIVE COMPARATOR

Ten patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft alone.

Other: Xenograft

Interventions

Melatonin gel mixed with xenograftDrug

This study will be conducted to evaluate the effect of melatonin (5% gel) when used as an adjunct to xenograft for the surgical management of intrabony periodontal defects.

Melatonin gel with Xenograft group

XenograftOther

Application of Xenograft alone for the surgical management of intrabony periodontal defects.

Xenograft Only group

Eligibility Criteria

Age35 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Both genders within age range of 35-55 years.
Patients diagnosed with periodontitis Stage III (Caton et al., 2018; Papapanou et al., 2018).

Sponsors & Collaborators

Ain Shams University
Otherlead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, 11511, Egypt

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Interventions

Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal investigator

Study Record Dates

First Submitted

January 8, 2025

First Posted

February 12, 2025

Study Start

January 1, 2025

Actual (reported)

Melatonin Gel as an Adjuvant in the Surgical Management of Intrabony Defects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Melatonin gel with Xenograft group

Xenograft Only group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Melatonin gel with Xenograft group

Xenograft Only group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations