Clinical and Radiographic Evaluation of Local Melatonin Application on Osseointegration of Immediate Mandibular Implants

N/AActive Not RecruitingNCT07374523

Suez Canal University16 enrolled

Overview

Clinical and Radiographic Evaluation of Local Application of Melatonin on Osseointegration of Immediate Dental Implants for Mandibular Single Rooted Teeth: A Randomized Controlled Study

Dental implant is a treatment option that offers great functional and biologic advantages alongside noticeable long-term success outcomes with survival rates exceeding 95% . Delayed implant placement has been widely and successfully used for replacing missing teeth However, there are some challenges faced with delayed implant placement protocol due to the postextraction alveolar ridge resorption in buccolingual and apicocoronal directions . The percentage of the post-extraction horizontal and vertical dimensional changes are 29-63% and 11-22% respectively . This is attributed to the disruption of vascular supply due to damage of periodontal ligament leading to pronounced bundle bone resorption . This pronounced post-extraction bone resorption usually leads to functional challenges and the need for augmentation procedures . In order to avoid such challenges, immediate post-extraction implant placement concept was introduced to avoid the bone resorption following tooth extraction and to reduce treatment time . Immediate implant placement showed a high overall implant placement rate reaching 97.1% as reported in the systematic review and 94.9% in the meta-analysis Although immediate implant placement is effective in preservation of the alveolar bone dimensions but it fails to completely prevent the postextraction dimensional changes . Therefore, attempts were done regarding placement of various biomaterials in the peri-implant gap to increase the immediate implant stability and to minimize or even prevent the post-extraction bone dimensional changes if possible. Multiple materials were successfully used such as bone grafting materials like xenografts , autogenous graftsin addition to the application of bone morphogenetic proteins (BMPs), platelet rich fibrin (PRF) . Melatonin (MLT) among these agents which are of a great interest for the recent researches whether in the medical or dental fields due to their confirmed physiological and structural functions, their biocompatibility and non-antigenic properties . MLT is a natural hormone with powerful antioxidant properties, released mainly the pineal gland . It is successfully used in various conditions as sleep disorders, cardiovascular, chronic inflammatory diseases and parkinsonism

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Implant Therapy

Interventions

Melatonin gelOTHER

the implant was placed with melatonin application (3mg Melatonin into 2ml of Hydroxyethyl Cellulose Gel 2%).

ControlOTHER

the implant was placed without melatonin.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged between 21 and 60 years. 2. Good general health (ASA I). 3. Non-smokers or light smokers (\<10 cigarettes/day). 4. Presence of a single non-restorable mandibular tooth indicated for extraction (incisor, canine, or premolar). 5. Adequate bone volume to receive a dental implant. 6. Patients with good oral hygiene. Exclusion Criteria: 1. Medically compromised patients (e.g., uncontrolled diabetes, immunosuppressive therapy, bisphosphonate use) 2. Pregnant and lactating women. 3. Active periodontal disease at the implant site. 4. Acute infection at the extraction site (abscess or sinus tract). 5. Severe parafunctional habits (e.g., bruxism, clenching).

Locations (1)

Faculty of Dentistry Suez Canal University

Ismailia, Egypt, Egypt

Outcomes

Primary Outcomes

Implant stability (ISQ)

Implant stability will be assessed using resonance frequency analysis and recorded as Implant Stability Quotient (ISQ) values on a scale from 1 to 100, where higher values indicate greater implant stability. ISQ values ≥70 indicate high stability; values 55-69 indicate moderate stability requiring monitoring; and values \<55 indicate low stability.

Time frame: Immediately postoperatively and at 6months postoperatively

Secondary Outcomes

post-operative pain (VAS)

Postoperative pain assessed using visual analogue scale (VAS) Visual Analog Scale (VAS) for Pain, Grades: 0 - No pain 1-3 - Mild pain (nagging, annoying, but not interfering with activities) 4-6 - Moderate pain (interferes significantly with activities) 7-10 - Severe pain (disabling, unable to perform activities)

Time frame: At 1, 3 and 7 days postoperatively

post-operative Edema

Post-operative Edema Scale (Grade 0-3) Grades: Grade 0: No edema observed Grade 1: Intraoral edema only Grade 2: Extraoral edema Grade 3: Diffuse edema involving both intraoral and extraoral areas

Time frame: At 1, 3 and 7 days postoperatively

Marginal bone loss

Marginal bone loss: Marginal bone loss will be measured using DIGORA software (Soredex, Helsinki, Finland) by calculating the vertical distance (in millimeters) from the implant shoulder/platform to the first bone-to-implant contact on the mesial and distal aspects.

Time frame: Immediately postoperatively (baseline) 3 months postoperatively 6 months postoperatively

Bone density

Peri-implant bone density will be assessed using DIGORA software (Soredex, Helsinki, Finland) by calculating mean gray scale values within a standardized region of interest (ROI) adjacent to the implant, where higher gray scale values indicate greater bone density.

Data from ClinicalTrials.gov

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