NCT07012564

Brief Summary

This randomized, split-mouth clinical trial investigates the effect of oral vitamin C supplementation on postoperative recovery following the surgical extraction of impacted mandibular third molars. Fifty-six healthy patients underwent bilateral extractions, with each side randomly assigned to receive either 1000 mg of oral vitamin C or a placebo. The supplementation began one day before surgery and continued through postoperative day 7. The outcome measures included facial swelling assessed through linear measurements (tragus-pogonion, tragus-commissure labiorum, and lateral canthus of the eye-angulus mandible), pain using a visual analog scale (VAS), trismus based on maximum interincisal opening, and early wound healing assessed with the Landry healing index. Analgesic consumption was also recorded. Pain was evaluated using VAS on days 1, 2, and 7. Edema, trismus, and early wound healing were evaluated on postoperative days 2 and 7. The study aims to determine whether vitamin C reduces edema, pain, and trismus, and enhances early soft tissue healing compared to placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Last Updated

June 10, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

May 31, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

Vitamin CWound HealingThird Molar SurgeryOral SurgeryPostoperative RecoveryTrismusFacial SwellingPainAnalgesic UseEdema

Outcome Measures

Primary Outcomes (2)

  • Postoperative Facial Swelling

    Facial swelling was measured using three linear distances: tragus-pogonion, tragus-labial commissure, and lateral canthus-mandibular angle.

    Postoperative Day 2 and Day 7

  • Postoperative Pain Score (VAS)

    Pain intensity was assessed using a 10-cm visual analog scale (VAS), with 0 = no pain and 10 = worst possible pain.

    Postoperative Days 1, 2, and 7

Secondary Outcomes (3)

  • Trismus (Maximum Interincisal Opening)

    Postoperative Days 2 and 7

  • Early Wound Healing (Landry Healing Index)

    Postoperative Days 2 and 7

  • Analgesic Consumption

    Postoperative Days 1,2 and 7

Study Arms (2)

Vitamin C

EXPERIMENTAL

Patients received 1000 mg of oral vitamin C daily starting one day before surgery through postoperative day 7.

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

Patients received an identical-looking placebo tablet once daily for the same duration.

Other: Placebo

Interventions

Vitamin CDIETARY_SUPPLEMENT

1000 mg oral vitamin C tablet taken daily from one day before surgery to postoperative day 7.

Vitamin C
PlaceboOTHER

Identical-appearing oral tablet taken on the same schedule as the vitamin C group.

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years
  • Systemically healthy
  • Non-smoker
  • No alcohol or substance abuse
  • Bilateral impacted mandibular third molars
  • Mesioangular impaction with a Pederson index of 5-6
  • Voluntary participation
  • Ability and willingness to attend follow-up visits

You may not qualify if:

  • Pregnancy or lactation
  • Presence of infection or pain related to third molars
  • Associated pathological conditions (e.g., cysts or tumors)
  • History of previous mandibular third molar extraction
  • Congenital absence of third molars
  • Known allergy to any drug or substance used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Dentistry

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

TrismusPainEdema

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

SpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
This study was designed as a double-blind trial. Both the participants and the outcome assessors were blinded to the allocation of the intervention (vitamin C or placebo). The tablets were identical in appearance, taste, and packaging to ensure blinding integrity. Allocation concealment was maintained by a third party responsible for randomization and distribution of the supplements. The clinical evaluator who performed the postoperative measurements (pain, swelling, trismus, and wound healing) was not informed about the intervention administered to each surgical site. Participants were also unaware of which side received vitamin C or placebo.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study employed a split-mouth crossover design, where each participant served as their own control. Bilateral surgical extractions of impacted mandibular third molars were performed in two separate sessions. The intervention (vitamin C) and the control (placebo) were randomly assigned to either the left or right surgical site, allowing intra-individual comparison of postoperative outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2025

First Posted

June 10, 2025

Study Start

June 1, 2024

Primary Completion

February 15, 2025

Study Completion

March 1, 2025

Last Updated

June 10, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations