Efficacy of Two Nutritional Supplements on Healing and Bone Density in the Jaws
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Universidad de Granada
- Enrollment
- 60
- Primary Endpoint
- diensional changes
Study Overview
Brief Summary
In view of the above and the possible improvements in terms of postoperative morbidity and tissue repair in oral surgery, this study is justified, the general objective of which would be:
'To evaluate the efficacy of perioperative oral administration of two nutritional supplements based on vitamins and antioxidants (Osteoimplant Complex® and Osteoimplant®), using mandibular third molar surgery as a study model, assessing postoperative symptomatology and bone density'.
The null hypothesis of this study is: 1) the administration of the perioperative nutritional complex (Osteoimplant Complex® and Osteoimplant®) did not improve postoperative symptoms and 2) neither did it increase bone density after lower third molar extraction.
Detailed Description
In view of the above and the possible improvements in terms of postoperative morbidity and tissue repair in oral surgery, this study is justified, the general objective of which would be:
'To evaluate the efficacy of perioperative oral administration of two nutritional supplements based on vitamins and antioxidants (Osteoimplant Complex® and Osteoimplant®), using mandibular third molar surgery as a study model, assessing postoperative symptomatology and bone density'.
The null hypothesis of this study is: 1) the administration of the perioperative nutritional complex (Osteoimplant Complex® and Osteoimplant®) did not improve postoperative symptoms and 2) neither did it increase bone density after lower third molar extraction.
Study design. It is a randomised clinical trial (RCT), double blind controlled (neither the patient nor the examiner collecting the data knows the allocation group) and split-mouth to evaluate the efficacy of the perioperative oral administration of two nutritional complexes on postoperative symptoms, wound healing and bone density 8 weeks after the extraction of a mandibular third molar.
Composition of the nutritional supplements. A. Preoperative nutritional supplement, Osteoimplant Complex®: Ovocet®, vitamin C 48.5mg, coenzyme Q10 41.3mg, zinc 35mg, beta carotene 10% 25mg, bioflavonoids citrus 60% 20.83mg, vitamin E, magnesium 15mg.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients presenting both lower third molars.
- •Adult patients between 18 and 40 years of age.
- •Anaesthetic risk ASA I-II (American Society of Anaesthesiologists classification) [14].
- •Absence of drug or food allergies that could compromise our study (e.g. egg).
- •Signed informed consent.
Exclusion Criteria
- •Age not between 18-40 years.
- •Pregnant or breastfeeding women.
- •Presenting decompensated metabolic disease.
- •Poor periodontal status (≥10% plaque index and bleeding index).
- •Patients who have undergone radiotherapy in the last five years.
- •Patients who will not comply with the study guidelines.
- •Unsigned informed consent.
- •History of allergy to any study medication or related drugs (e.g. egg).
- •Patients with a history of renal colic.
Arms & Interventions
placebo
Intervention: Placebo (Drug)
osteoimplant
Intervention: osteoimplant (Drug)
Outcomes
Primary Outcomes
diensional changes
Time Frame: From the extraction (T0) to 8 weeks after (T1) extraction
Dimensional changes shall be assessed by a surgeon previously instructed by a specialised radiologist, by means of CBCT scans performed before (T0) and 8 weeks after (T1) extraction to obtain thus: Dimensional changes, evaluating the horizontal and vertical dimensions of hard tissue taking as a reference the amelocentric limit (LAC) of the adjacent tooth, so as to assess whether there has been loss of hard tissue following extraction and healing. For this purpose, three sections (A, B and C) shall be made at 5, 7 and 9 mm, taking as point 0 the imaginary horizontal line marked by the LAC of the adjacent tooth.
Secondary Outcomes
No secondary outcomes reported
Investigators
Francisco Javier Manzano-Moreno
PhD, DDS
Universidad de Granada