Clinical trial NCT03540316: Treatment Outcome of Short Implant Assisted Mandibular Overdenture
Official title: Treatment Outcome of Short Implant Assisted Mandibular Overdenture in Combination With Low Level Laser Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophy of Edentulous Mandibular Alveolar Ridge
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 12
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short implants.

Detailed description: The conventional solution to complete edentulism is the use of complete removable dentures. One negative effect of edentulism is resorption of the edentulous ridge over time. Construction of a successful mandibular complete denture for patients with advanced mandibular ridge resorption is often difficult and on some occasions virtually impossible. It has been proved that when implants are placed, bone gets stimulated resulting in minimal bone loss. But anatomic limitations to implant placement have been observed in atrophic ridges, so short implants introduced as a recent alternative to aggressive surgical procedures proposed to compensate for tissue deficiency. Also, Low Level Laser Therapy (LLLT) has proven success in improving implant stability which is very crucial in short implants. Thus, the purpose of this study is to evaluate and compare the treatment outcome of mandibular overdenture assisted by two short implants versus that assisted by four short implants in combination with LLLT.

Eligibility criteria: Inclusion Criteria:

* Completely edentulous patients.
* Patients with mandibular resorbed edentulous ridge.
* Medically fit patients with no systemic conditions.
* Class I ridge relation.
* Adequate zone of keratinized mucosa.

Exclusion Criteria:

* Metabolic bone disease or unstable systemic condition.
* Heavy smokers.
* A history of radiotherapy in the head and neck region.
* Physical or mental disability.
* Temporomandibular and neuromuscular disorders.

Primary outcomes:
measure: Assessment of changes in implant stability (Implant Stability Quotient).
timeFrame: Baseline, 6 months &12 months.
Secondary outcomes:
measure: Peri-implant marginal bone changes.
timeFrame: Baseline, 6 months &12 months.
measure: Assessment of changes in peri-implant probing depth .
timeFrame: Baseline, 6 months &12 months.
measure: Assessment of changes in modified gingival index
timeFrame: Baseline, 6 months &12 months.
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of dentistry
Study officials:
affiliation: Alexandria University
name: Sara Zayed
role: STUDY_DIRECTOR
References:
citation: Thomason JM, Feine J, Exley C, Moynihan P, Muller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728.
citation: Maniewicz S, Buser R, Duvernay E, Vazquez L, Loup A, Perneger TV, Schimmel M, Muller F. Short Dental Implants Retaining Two-Implant Mandibular Overdentures in Very Old, Dependent Patients: Radiologic and Clinical Observation Up to 5 Years. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):415-422. doi: 10.11607/jomi.5361.
citation: Mandic B, Lazic Z, Markovic A, Mandic B, Mandic M, Djinic A, Milicic B. Influence of postoperative low-level laser therapy on the osseointegration of self-tapping implants in the posterior maxilla: a 6-week split-mouth clinical study. Vojnosanit Pregl. 2015 Mar;72(3):233-40. doi: 10.2298/vsp131202075m.
citation: Malo P, de Araujo Nobre M, Rangert B. Short implants placed one-stage in maxillae and mandibles: a retrospective clinical study with 1 to 9 years of follow-up. Clin Implant Dent Relat Res. 2007 Mar;9(1):15-21. doi: 10.1111/j.1708-8208.2006.00027.x.
citation: Zayed SM, Noureldin MG. Rehabilitation of Atrophic Mandible with Ultrashort Implants Combined with Photobiomodulation Therapy: A Split-Mouth Design Study. Saudi J Med Med Sci. 2022 Sep-Dec;10(3):198-206. doi: 10.4103/sjmms.sjmms_635_21. Epub 2022 Aug 22.