Osteoimplant and Bone Healing

NCT06664060 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 4042/CEIH/2024
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dimensional Changes; Bone Density

Keywords

vitamin d; vitamin c; bone density; dimensional changes

Outcome Measures

Primary Outcomes (1)

• diensional changes

  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.

  From the extraction (T0) to 8 weeks after (T1) extraction

Study Arms (2)

osteoimplant

EXPERIMENTAL

Drug: osteoimplant

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

osteoimplant DRUG

30 lower third molars will be selected and prescribed preoperative treatment with two units of Osteoimplant Complex® 5 days prior to surgery and postoperative treatment with one unit of Osteoimplant® for 8 weeks from the time of surgery. Both nutritional supplements will be administered every 24 hours.

osteoimplant

Placebo DRUG

30 lower wisdom teeth will be selected and prescribed placebo, both preoperatively 5 days prior to surgery and postoperatively for 8 weeks from the time of surgery.

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Related Publications (3)

• Pisalsitsakul N, Pinnoi C, Sutanthavibul N, Kamolratanakul P. Taking 200 mg Vitamin C Three Times per Day Improved Extraction Socket Wound Healing Parameters: A Randomized Clinical Trial. Int J Dent. 2022 Mar 10;2022:6437200. doi: 10.1155/2022/6437200. eCollection 2022.

  PMID: 35310461 RESULT

• Olmedo-Gaya MV, Manzano-Moreno FJ, Munoz-Lopez JL, Vallecillo-Capilla MF, Reyes-Botella C. Double-blind, randomized controlled clinical trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction. Clin Oral Investig. 2018 Dec;22(9):2981-2988. doi: 10.1007/s00784-018-2386-1. Epub 2018 Feb 15.

  PMID: 29450738 RESULT

• Insua A, Galindo-Moreno P, Miron RJ, Wang HL, Monje A. Emerging factors affecting peri-implant bone metabolism. Periodontol 2000. 2024 Feb;94(1):27-78. doi: 10.1111/prd.12532. Epub 2023 Oct 30.

  PMID: 37904311 RESULT

Central Study Contacts

FRANCISCO JAVIER MANZANO-MORENO MANZANO-MORENO, PhD

CONTACT

+34651606228; fjmanza@ugr.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DDS

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: January 7, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share