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Studying patient outcomes after placing wide dental implants immediately in the first lower molar without surgery

Patient reported and clinical outcomes following flapless, immediate placement of ultra wide implants in first lower molars

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79633450
Enrollment
42
Registered
2025-09-08
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate implant placement (IIP) Oral Health

Interventions

All enrolled participants (single-arm cohort) will undergo atraumatic, flapless extraction of the designated unrestorable mandibular or maxillary molar using sectioning techniques to preserve all four

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Presence of a permanent first mandibular molar indicated for extraction and immediate implant placement, with the extraction socket classified as Class I according to Elian et al. (2007) 2. Age =18 years 3. Presence of adjacent teeth to the tooth indicated for extraction. 4. Tooth indicated for extraction is free from acute infection (no periapical swelling or fistula) 5. Intact buccal plate at the extraction site, either before or after extraction 6. Absence of dehiscence or fenestration defects 7. Presence of =2 mm width of keratinized mucosa at the extraction/implant site 8. Good oral hygiene (plaque index =20% according to the O’Leary index)

Exclusion criteria

Exclusion criteria: 1. Systemic conditions: uncontrolled diabetes, bleeding or coagulation disorders, history of head and neck radiotherapy or chemotherapy within the last 6 months 2. Current use of medications affecting bone healing or oral surgery (e.g., corticosteroids, oral anticoagulants) 3. Patients who are smokers or alcohol-dependent 4. Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
Implant success rate measured by the dental researcher 4 months after the first surgical stage, according to the Pisa consensus criteria of the International Congress of Oral Implantologists (ICOI)

Secondary

MeasureTime frame
1. Implant survival rate measured by the dental researcher, defined as the proportion of implants remaining functional and in situ (not lost or failed), during the study period 2. Days of impaired daily activity, measured using self-reported in a diary as the number of days the patient was unable to fully or partially perform daily activities, during the first postoperative week 3. Postoperative pain was assessed by measuring daily pain levels using a Visual Analogue Scale (VAS), and self-reporting of the number of analgesic tablets consumed, during the first postoperative week 4. Postoperative swelling (edema) was measured using a 4-point scale (0: none, 1: mild, 2: moderate, 3: severe) during the first postoperative week 5. Surgical and postoperative complications were assessed by measuring: 5.1. Intraoperative: bleeding, injury to adjacent structures, implant displacement, buccal plate integrity (yes/no, reported by clinician/patient). 5.2. Postoperative: early implant loss, bleeding, soft tissue dehiscence or infection at 1 week, 2 weeks, and 4 months 6. Marginal bone level (MBL): Measured mesially and distally using standardized digital radiographs (parallel technique with sensor holder), immediately after placement and after 4 months. Bone loss calculated with ImageJ software 7. Insertion torque: Maximum torque value recorded during implant placement (N·cm) 8. Implant stability (Resonance Frequency Analysis, RFA): Implant Stability Quotient (ISQ) values measured at 4 sites (mesial, distal, buccal, lingual) immediately after placement and at 4 months, averaged per implant 9. Osseointegration: measured using a reverse torque test (=32 N·cm) after 4 months 10. Patient satisfaction: measured using a 5-point Likert scale (1: strongly agree, 5: strongly disagree) at 4 months post-surgery 11. Soft tissue biotype: Thin vs thick biotype assessed by probe transparency test at baseline and 4 months 12. Height of attached mucosa: Measured with periodontal probe at bas

Countries

Syria

Contacts

Public ContactFouad Agha
aghafouad47@gmail.com+963988261146

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026