Periodontal Disease, AVDC Stage 3Phase 4NCT06821425
Melatonin Gel as an Adjuvant in the Surgical Management of Intrabony Defects
A Phase 4 study testing Melatonin gel mixed with xenograft and Xenograft in people with Periodontal Disease, AVDC Stage 3, run by Ain Shams University at 1 site in Egypt.
Trial summary
Surgical periodontal therapy is a commonly employed treatment approach aimed at arresting disease progression and promoting tissue regeneration. Despite advancements in surgical techniques, adjunctive therapies are being explored to enhance the outcomes of periodontal surgical debridement. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Periodontal Disease, AVDC Stage 3
- What is being tested?
- Melatonin gel mixed with xenograft and Xenograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders within age range of 35-55 years.
- Patients diagnosed with periodontitis Stage III (Caton et al., 2018; Papapanou et al., 2018).
- Test site criteria: (probing pocket depth ≥6mm and CAL ≥5mm and 3-wall intrabondy defect). All these criteria will be determined after phase I conventional periodontal therapy.
- Patients with three-wall intrabony defects.
- Systemically free patients as evidenced by Burket's oral health history questionnaire (Glick et al., 2008)
- Ability to attend the treatment sessions and comply with the procedures, recall visits and oral hygiene measures.
Who cannot join
- Smokers. (Reynolds et al., 2015)
- Drug abusers.
- Pregnant or lactating females.
- Patients under any medication that affect periodontal healing.
- Vulnerable individuals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Melatonin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects (A Randomized Controlled Clinical Study)
Surgical periodontal therapy is a commonly employed treatment approach aimed at arresting disease progression and promoting tissue regeneration. Despite advancements in surgical techniques, adjunctive therapies are being explored to enhance the outcomes of periodontal surgical debridement. Melatonin, a hormone primarily known for its role in regulating the sleep-wake cycle, has emerged as a promising candidate for periodontal therapy. It possesses potent antioxidant, anti-inflammatory, and immunomodulatory properties, which make it an attractive therapeutic agent for treating periodontitis. Additionally, melatonin has been linked to bone metabolism, with evidence suggesting its involvement in bone formation and remodeling processes. Bone regeneration is a vital aspect of periodontal therapy, as the restoration of lost osseous structures is crucial for long-term stability of affected teeth. Previous studies have suggested that melatonin may exert positive effects on bone formation by promoting osteoblast differentiation, stimulating matrix synthesis, and inhibiting osteoclast activity. However, limited research has been conducted to specifically evaluate its influence on bone regeneration in the context of surgical periodontal flap therapy.
- Conditions
- Periodontal Disease, AVDC Stage 3
- Being tested
- Melatonin gel mixed with xenograft, Xenograft
- Keywords
- Stage III periodontitis, Melatonin gel, Xenograft
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
XenograftOther
Application of Xenograft alone for the surgical management of intrabony periodontal defects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Radiographic evaluation of the changes in the intrabony defect
The amount of bone gain in millimeters in follow up radiograph compared to preoperative radiograph
Measured: 6 months
Secondary outcomes (2)
Clinical evaluation of the changes in periodontal parameters
The amount of reduction in Probing pocket depth (PD) in mm The new level of clinical attachment (CAL) in relation the CEJ in mm
Measured: Baseline and 6 months
Evaluation of surgical wound healing
Early Healing Index (EHI) to assess the quality of a wound in the days or weeks following a procedure, developed by Wachtel et al. to evaluate flap closure, the presence and amount of fibrin (a blood clot component), and the degree of tissue necrosis. A lower EHI score (such as 1-3) indicates better, complete healing, whereas higher scores (e.g., 4-5) suggest incomplete or poor healing.
Measured: 1 and 2 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Jan 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Disease, AVDC Stage 3Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Abdelnasser Ali Elnaggar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821425
- Sponsor's protocol ID
- FDASU-RecIM122330
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects (A Randomized Controlled Clinical Study)
- ClinicalTrials.gov ID
- NCT06821425
- Acronym / sponsor ID
- FDASU-RecIM122330
- Conditions
- Periodontal Disease, AVDC Stage 3
- Keywords
- Stage III periodontitis, Melatonin gel, Xenograft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical periodontal therapy is a commonly employed treatment approach aimed at arresting disease progression and promoting tissue regeneration. Despite advancements in surgical techniques, adjunctive therapies are being explored to enhance the outcomes of periodontal surgical debridement. Melatonin, a hormone primarily known for its role in regulating the sleep-wake cycle, has emerged as a promising candidate for periodontal therapy. It possesses potent antioxidant, anti-inflammatory, and immunomodulatory properties, which make it an attractive therapeutic agent for treating periodontitis. Additionally, melatonin has been linked to bone metabolism, with evidence suggesting its involvement in bone formation and remodeling processes. Bone regeneration is a vital aspect of periodontal therapy, as the restoration of lost osseous structures is crucial for long-term stability of affected teeth. Previous studies have suggested that melatonin may exert positive effects on bone formation by promoting osteoblast differentiation, stimulating matrix synthesis, and inhibiting osteoclast activity. However, limited research has been conducted to specifically evaluate its influence on bone regeneration in the context of surgical periodontal flap therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin gel with Xenograft group | Experimental | Drug: Melatonin gel mixed with xenograftTen patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft mixed with 5% melatonin gel. |
| Xenograft Only group | Active comparator | Other: XenograftTen patients with stage III periodontitis with vertical bone defects will be subjected to application of particulate xenograft alone. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both genders within age range of 35-55 years.
- Patients diagnosed with periodontitis Stage III (Caton et al., 2018; Papapanou et al., 2018).
- Test site criteria: (probing pocket depth ≥6mm and CAL ≥5mm and 3-wall intrabondy defect). All these criteria will be determined after phase I conventional periodontal therapy.
- Patients with three-wall intrabony defects.
- Systemically free patients as evidenced by Burket's oral health history questionnaire (Glick et al., 2008)
Key exclusion criteria (5 listed)
- Smokers. (Reynolds et al., 2015)
- Drug abusers.
- Pregnant or lactating females.
- Patients under any medication that affect periodontal healing.
- Vulnerable individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin gel mixed with xenograftThis 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. | Drug | Melatonin gel with Xenograft group |
| XenograftApplication of Xenograft alone for the surgical management of intrabony periodontal defects. | Other | Xenograft Only group |
Primary outcome
- Radiographic evaluation of the changes in the intrabony defect
Time frame: 6 months
The amount of bone gain in millimeters in follow up radiograph compared to preoperative radiograph
2 secondary outcomes
Clinical evaluation of the changes in periodontal parameters
Time frame: Baseline and 6 months
Evaluation of surgical wound healing
Time frame: 1 and 2 weeks after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontal Disease, AVDC Stage 3
Active, not recruiting
ABX Versus CHX in NSPT
Periodontal Disease, Periodontal Disease Stage 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin gel mixed with xenograft and Xenograft in people with Periodontal Disease, AVDC Stage 3, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Radiographic evaluation of the changes in the intrabony defect (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.