Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes After Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Suez Canal University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Bone density
Overview
Brief Summary
Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes after Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study
Detailed Description
of all impacted teeth. The frequency of impaction of the mandibular third molar ranges from 33% to 58.7% (Breik O and Grubor D.,2008). A tooth is considered to be impacted when its eruption time has passed or when the eruption interferes with the normal functional occlusion with other teeth or the overlying bone or soft tissues in the oral cavity (Celikoglu et al.,2010)).
The surgical removal of an impacted third molar is an everyday procedure in oral surgery clinics. However, it is known to disturb the quality of life of the patient by restricting the ability to chew food, open the mouth, and speak (Lago-Mendez et al., 2007). Furthermore, there is a danger of periodontal damage on the distal root of the adjacent molar which could affect healing (Richardson et al., 2005), 43% of the patients had a periodontal pocket depth of 7 mm or more at the distal root of the mandibular second molar 2 years post extraction of an impacted mandibular third molar.
The healing of periodontal defects related to the distal root of the adjacent molar may be compromised by intra-bony defects and bone loss after the removal of the impacted tooth. Alternative strategies, such as different flap designs, soft-tissue suturing, socket preservation, and tissue regeneration techniques with autologous bone, allografts, xenografts, or alloplastic grafts, have been proposed to prevent periodontal defects and physiological bone resorption after the surgical extraction of the mandibular third molar (Toledano-Serrabona et al.,2021).
Melatonin is a growth hormone secreted mainly by the pineal gland and other structures, such as the retina, skin, gastrointestinal tract, lymphocytes, and bone marrow (Radogna et al.,2010).It has antioxidant and anti inflammatory properties. It inhibits the production of reactive oxidants by reducing the expression of cyclooxygenase-2 and prostaglandin. In addition, it attracts polymorphonuclear cells to the site of injury (Cutando et al.,2007).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both genders are included. 2)Adult patients (18-40) years 3)Healthy American Society of Anesthesiologists ASA I Patients. 4)Patients with class I or II impacted lower third molars with position A or B.
Exclusion Criteria
- •Pregnant \& lactating women.
- •Smoker patients.
- •Patients with poor oral hygiene.
- •Patients with bad oral habits as bruxism.
- •Patients with periapical or peri coronal lesions.
- •Patients with aggressive gingivitis or periodontitis.
Arms & Interventions
Control without Melatonin
(the extraction socket will be left empty followed by suture of the socket after extraction
Intervention: Control (Diagnostic Test)
Control without Melatonin
(the extraction socket will be left empty followed by suture of the socket after extraction
Intervention: Melatonin gel (Dietary Supplement)
Study with Melatonin
3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction
Intervention: Control (Diagnostic Test)
Study with Melatonin
3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction
Intervention: Melatonin gel (Dietary Supplement)
Outcomes
Primary Outcomes
Bone density
Time Frame: 1 and 4 months postoperatively
Assess relative bone density at the center of the extracted socket using digital periapical radiograph in the center of the socket.
Secondary Outcomes
- Post-operative pain levels(1, 3 and 7 days Postoperatively)
- Measure Edema scale(1, 3 and 7 days Postoperatively)
- Measure Maximal Mouth opening (MMO)(1, 3 and 7 days Postoperatively)
- Measure the incidence of post-operative complications(1, 3 and 7 days Postoperatively)