Early Loading of UV-Functionalized Dental Implants

NCT07694388 | Completed

• 1 other identifier: UDDS-2026-OralMaxillofacial-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled triple-blind split-mouth clinical trial was conducted to evaluate the effect of early loading on ultraviolet photofunctionalized dental implants placed in the posterior mandible. Ten patients received a total of 20 implants, with each participant receiving one ultraviolet photofunctionalized implant and one non-photofunctionalized control implant. Ultraviolet photofunctionalization was performed 24 hours before implant placement by an independent investigator. All implants were early loaded 4 weeks after surgery. Implant stability was assessed using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values at implant placement, 3 weeks, and 4 weeks after surgery. Peri-implant marginal bone loss was evaluated radiographically during a one-year follow-up period. The study compared implant stability and radiographic outcomes between ultraviolet photofunctionalized and conventional implants under early loading conditions.

Conditions

Posterior Mandibular Partial Edentulism

Outcome Measures

Primary Outcomes (1)

• Implant Stability Quotient (ISQ)

  Implant stability was measured using Resonance Frequency Analysis (RFA) with the Mega ISQ II device. Stability values were recorded as Implant Stability Quotient (ISQ) scores ranging from 1 to 100, with higher values indicating greater implant stability. Measurements were obtained immediately after implant placement, at 3 weeks, and at 4 weeks postoperatively before early loading.

  At implant placement (baseline), 3 weeks after implant placement, and 4 weeks after implant placement.

Secondary Outcomes (1)

• Peri-implant Marginal Bone Loss

  At implant placement (baseline) and one year after early loading.

Study Arms (2)

Arm 1: Ultraviolet Photofunctionalized Dental Implants

EXPERIMENTAL

This arm included dental implants that underwent ultraviolet photofunctionalization 24 hours before implant placement. Each participant received one ultraviolet photofunctionalized implant in a posterior mandibular edentulous site according to the randomized split-mouth design.

Procedure: Ultraviolet Photofunctionalization

Conventional Dental Implants

ACTIVE COMPARATOR

This arm included dental implants placed without ultraviolet photofunctionalization. Each participant received one conventional implant in a comparable posterior mandibular edentulous site according to the randomized split-mouth design.

Procedure: Conventional Implant Placement

Interventions

Ultraviolet Photofunctionalization PROCEDURE

Dental implants assigned to the experimental arm underwent ultraviolet photofunctionalization 24 hours before implant placement by an independent investigator. The implants were subsequently placed in posterior mandibular edentulous sites and restored using an early loading protocol 4 weeks after surgery

Arm 1: Ultraviolet Photofunctionalized Dental Implants

Conventional Implant Placement PROCEDURE

Dental implants assigned to the control arm were placed without ultraviolet photofunctionalization. The implants were inserted in comparable posterior mandibular edentulous sites and restored using the same early loading protocol 4 weeks after surgery

Conventional Dental Implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate in the study and provision of written informed consent, with commitment to follow-up visits and study instructions.
• Good oral hygiene and satisfactory oral health status.
• Adults aged 18 years or older.
• Good general health with no systemic conditions contraindicating dental implant placement.
• Requirement for dental implant placement in the posterior mandible, with at least 6 months elapsed since tooth extraction.
• Adequate bone volume to allow implant placement without the need for bone grafting procedures.

You may not qualify if:

• Patients with parafunctional habits, including bruxism.
• Heavy smokers consuming more than 10 cigarettes per day.
• Patients receiving radiotherapy or chemotherapy.
• Long-term use of medications known to affect bone metabolism, such as corticosteroids.
• Pregnant or breastfeeding women.
• Insufficient interocclusal space for prosthetic rehabilitation.
• Patients with metabolic or bone disorders affecting bone quality or density, including hyperparathyroidism and osteoporosis.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery Faculty of Dentistry Damascus University Damascus, Syrian Arab Republic

Damascus, Syria

Location

Related Publications (5)

• Funato A, Yamada M, Ogawa T. Success rate, healing time, and implant stability of photofunctionalized dental implants. Int J Oral Maxillofac Implants. 2013 Sep-Oct;28(5):1261-71. doi: 10.11607/jomi.3263.

  PMID: 24066316 BACKGROUND

• Monje A, Ravida A, Wang HL, Helms JA, Brunski JB. Relationship Between Primary/Mechanical and Secondary/Biological Implant Stability. Int J Oral Maxillofac Implants. 2019 Suppl;34:s7-s23. doi: 10.11607/jomi.19suppl.g1.

  PMID: 31116830 BACKGROUND

• Dini C, Nagay BE, Magno MB, Maia LC, Barao VAR. Photofunctionalization as a suitable approach to improve the osseointegration of implants in animal models-A systematic review and meta-analysis. Clin Oral Implants Res. 2020 Sep;31(9):785-802. doi: 10.1111/clr.13627. Epub 2020 Jul 2.

  PMID: 32564392 BACKGROUND

• Hirota M, Ozawa T, Iwai T, Mitsudo K, Ogawa T. UV-Mediated Photofunctionalization of Dental Implant: A Seven-Year Results of a Prospective Study. J Clin Med. 2020 Aug 24;9(9):2733. doi: 10.3390/jcm9092733.

  PMID: 32847061 BACKGROUND

• Choi B, Lee YC, Oh KC, Lee JH. Effects of photofunctionalization on early osseointegration of titanium dental implants in the maxillary posterior region: a randomized double-blinded clinical trial. Int J Implant Dent. 2021 May 10;7(1):37. doi: 10.1186/s40729-021-00318-x.

  PMID: 33969450 BACKGROUND

Study Officials

• Issam Alkhouri, DDS, Phd

  Faculty of Dentistry, Damascus University, Damascus, Syria

  STUDY CHAIR

• Awab Al-Midani, Master's Degree Candidate

  Faculty of Dentistry, Damascus University, Damascus, Syria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors were blinded to treatment allocation. Ultraviolet photofunctionalization was performed 24 hours before surgery by an independent operator who was not involved in implant placement, follow-up assessments, or data analysis. Implant allocation was concealed using coded assignments. The surgeon who performed implant placement and evaluated implant stability (ISQ) and marginal bone loss remained unaware of group allocation throughout the study. Statistical analyses were conducted using anonymized datasets without disclosure of treatment identities until completion of the final analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study used a randomized split-mouth design in which each participant received one ultraviolet-photofunctionalized implant and one implant that did not undergo ultraviolet treatment in contralateral posterior mandibular sites. This design enabled within-subject comparisons while minimizing inter-individual variability.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: December 11, 2022
• Primary Completion: February 8, 2025
• Study Completion: March 8, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)