Laser Modification of Dental Implant Abutment Surfaces

NCT07780227 — Not applicable, Completed, 24 participants, Alexandria University

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Impact of Surface Modification of Abutments of Dental Implants by Laser on Soft Tissue Seal (A Randomized Controlled Clinical Trial)

Registry	NCT07780227
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	Alexandria University (Other)
Conditions	Dental Implants
Interventions	ND: YAG laser, Machined abutment (Other)
Dates	start 2025-06-15, primary completion 2025-12-25, completion 2025-12-30, first posted 2026-08-21, last updated 2026-08-21
Locations	1 site in Egypt

-Summary

Introduction: Tight soft tissue integration to the dental implants is essential to achieve a successful outcome of dental implants. Contamination by oral bacteria of the implant-mucosa interface can result in gingival recession, pocket formation, and bone resorption. There are many surface modification strategies to reinforce the soft tissue seal to dental implants. One of these strategies is laser technology. The aim of this study is to evaluate the effect of laser-induced roughness of titanium surfaces of final abutments on the connective tissue seal to the dental implant. Materials and Methods: Twenty-four pure titanium abutments of dental implants will be evaluated in this study. The abutments will be divided into 2 groups: group A will be treated with ND: YAG laser, and group B will not be treated with a laser as a control group. After 3 months, evaluation will be done by measuring peri-implant probing depth, modified gingival index, bleeding index, plaque index, and patient satisfaction.

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+Arms and interventions

Arm	Type	Interventions	Description
Study group	Experimental	Other: ND: YAG laser
Control Group	Active comparator	Other: Machined abutment

ND: YAG laser (Other): This will include twelve titanium abutments treated by ND: YAG laser with an output power 4 W, representing 80mJ for a period of 5 seconds (20).
Machined abutment (Other): will include twelve abutments which will be left machined (as received from the manufacturer) to serve as controls.

+Outcome measures

Primary outcomes

change in peri-implant probing depth [up to 3 months]: Desirable probing depths around dental implants are 2.5mm to 4mm. Peri-implantitis is often defined by the incidence of peri-implant probing depth ≥ 5 mm associated with bleeding on probing

Secondary outcomes

change in Modified gingival index (MGI) [up to 3 months]: the scoring will be as follows: 0 = absence of inflammation, 1. = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit, 2. = mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit, 3. = moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, 4. = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
chaneg in Bleeding index (BI) [up to 3 months]: The Bleeding Index (modified Index of Saxton), will be performed by using a dental probe. The probe will be engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure will be used while sweeping. The scoring system is as follows: 0 = no bleeding after 30 seconds, 1 = bleeding upon probing after 30 seconds, 2 = immediate bleeding observed
change in Plaque index [up to 3 months]: 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth. 3 = a band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth, 4= more than 1/3 but less than 2/3 of the tooth is covered with plaque , 5 indicated that more than 2/3 of the tooth surface is covered with plaque
Patient satisfaction [up to 3 months]: Patient satisfaction will be assessed using a visual analogue scale (VAS)

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* An informed consent will be signed from all the volunteers and they will be informed with all the steps, risk and benefits regarding the study.
* Patients having osseointegrated implants ready to receive final abutment.

Exclusion Criteria:

* The presence of chronic systemic disease.
* Smoking of more than 10 cigarettes per day.
* Bruxism habits.
* Alcohol or drug abuse.
* Poor oral hygiene.
* Pregnancy

+Locations (1)

Facility	City	Country	Status
Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Egypt