--- title: Dry Needling Versus Stabilization Splint Therapy in Bruxism Associated Myofascial Temporomandibular Disorders nct_id: NCT07511335 overall_status: COMPLETED phase: NA sponsor: Kocaeli University study_type: INTERVENTIONAL primary_condition: Bruxism countries: Turkey (Türkiye) canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07511335.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07511335" ct_last_update_post_date: 2026-04-13 last_seen_at: "2026-05-12T06:00:20.968Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Dry Needling Versus Stabilization Splint Therapy in Bruxism Associated Myofascial Temporomandibular Disorders **Official Title:** Dry Needling Versus Stabilization Splint Therapy in Bruxism Associated Myofascial Temporomandibular Disorders: A Prospective Comparative Study **NCT ID:** [NCT07511335](https://clinicaltrials.gov/study/NCT07511335) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 40 - **Lead Sponsor:** Kocaeli University - **Conditions:** Bruxism, Dry Needling, Stabilization Splint - **Start Date:** 2019-02-26 - **Completion Date:** 2022-01-31 - **CT.gov Last Update:** 2026-04-13 ## Brief Summary This prospective comparative clinical study included 40 patients diagnosed with myofascial TMD who met the diagnostic criteria for bruxism established by the American Academy of Sleep Medicine. Participants were allocated into two groups according to treatment preference: stabilization splint therapy or dry needling. Maximum mouth opening (MMO), pain intensity assessed using the Visual Analog Scale (VAS), and Oral Health Impact Profile for TMD (OHIP-TMD) scores were recorded at baseline and at 1, 3, and 6 months post-treatment. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Adults aged ≥18 years * Clinical presence of temporomandibular disorder (TMD) symptoms (e.g., joint sounds such as clicking, and/or limited mouth opening) * Diagnosis of bruxism according to the American Academy of Sleep Medicine (AASM) criteria * Moderate to severe pain in the masseter and/or temporalis muscles, defined as a Visual Analog Scale (VAS) score ≥3.5 Exclusion Criteria: * Presence of connective tissue disorders or autoimmune diseases * Current use of systemic steroids, muscle relaxants, or narcotic (opioid) medications * History of neuromuscular disorders * Previous temporomandibular joint (TMJ) surgery * History of significant TMJ trauma * Presence of dentofacial deformities * Any condition that, in the opinion of the investigator, may interfere with study participation or outcome assessment ``` ## Arms - **Stabilization Splint Therapy** (ACTIVE_COMPARATOR) — Patients received a maxillary hard acrylic stabilization splint designed to provide uniform occlusal contacts. Participants were instructed to use the splint for at least two-thirds of the day over a 6-month period, except during eating and oral hygiene procedures. Monthly follow-up visits were conducted for necessary adjustments. - **Dry Needling** (EXPERIMENTAL) — Patients underwent dry needling applied to the masseter and temporalis muscles. The procedure was performed using sterile acupuncture needles in three sessions at 1-week intervals. Needles were inserted into identified trigger points and manually stimulated during each session. ## Interventions - **Stabilization Splint** (DEVICE) — A maxillary hard acrylic stabilization splint was fabricated to provide uniform occlusal contacts in centric occlusion. Patients were instructed to use the splint for at least two-thirds of the day over a period of 6 months, except during eating and oral hygiene procedures. Monthly follow-up visits were conducted for occlusal adjustments. - **Dry Needling** (PROCEDURE) — Dry needling was applied to the masseter and temporalis muscles using sterile acupuncture needles. The procedure targeted myofascial trigger points and was performed in three sessions at 1-week intervals. Needles were inserted into the identified نقاط and manually stimulated during each session. ## Primary Outcomes - **Pain intensity (VAS)** _(time frame: Baseline, 1 month, 3 months, and 6 months)_ — Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Measurements were recorded at baseline and during follow-up visits to evaluate changes in pain levels over time. - **Maximum mouth opening (MMO)** _(time frame: Baseline, 1 month, 3 months, and 6 months)_ — Maximum mouth opening (MMO) was measured in millimeters as the distance between the incisal edges of the maxillary and mandibular central incisors at maximum painless mouth opening. This parameter was used to assess functional improvement in mandibular mobility. ## Secondary Outcomes - **Oral Health-Related Quality of Life (OHIP-TMD)** _(time frame: Baseline, 3 months, and 6 months)_ ## Locations (1) - Kocaeli University, Kocaeli, Turkey (Türkiye) ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.kocaeli university|kocaeli||turkey (türkiye)` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07511335.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07511335* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*